Real-World Spirometry in the Workplace Townsend, M… · M.C. Townsend Associates, LLC •...

M.C. Townsend Associates, LLC • http://www.mctownsend.com 412-343-9946 • [email protected] -

COMPLETE POWERPOINT AND OTHER HANDOUTS WILL BE MADE AVAILABLE IN THE SESSION TO PARTICIPANTS.

A comprehensive current reference list is attached.

RealReal--World Spirometry in the WorkplaceWorld Spirometry in the Workplace

AOHC 2402AOHC 2402 May 5, 2010May 5, 2010

Mary C. Townsend, Dr.P.H.Mary C. Townsend, Dr.P.H.M. C. Townsend Associates, LLCM. C. Townsend Associates, LLCAdjunct Faculty, Univ. of PittsburghAdjunct Faculty, Univ. of PittsburghPittsburgh, PAPittsburgh, PA

William L. Eschenbacher, MDWilliam L. Eschenbacher, MDPulmonary PhysicianPulmonary PhysicianVA Medical CenterVA Medical CenterCincinnati, OHCincinnati, OH

RealReal--World Spirometry in the WorkplaceWorld Spirometry in the Workplace

AOHC 2402AOHC 2402 May 5, 2010May 5, 2010

Mary C. Townsend, Dr.P.H.Mary C. Townsend, Dr.P.H.M. C. Townsend Associates, LLCM. C. Townsend Associates, LLCAdjunct Faculty, Univ. of PittsburghAdjunct Faculty, Univ. of PittsburghPittsburgh, PAPittsburgh, PA

William L. Eschenbacher, MDWilliam L. Eschenbacher, MDPulmonary PhysicianPulmonary PhysicianVA Medical CenterVA Medical CenterCincinnati, OHCincinnati, OH


PHONE NUMBERS & WEBSITES 1. American Thoracic Society (ATS) Official Statements on webpage: http://www.thoracic.org/statements/index.php 2. American College of Occupational and Environmental Medicine (ACOEM) Statements:

http://www.acoem.org/guidelines.aspx 3. National Heart, Lung, and Blood Institute (NHLBI): 301-592-8573 http://www.nhlbi.nih.gov/health/pubs/pub_prof.htm 4. Global Initiative for Asthma (GINA) http://www.ginasthma.com/ 5. Medical Surveillance for Flavorings�Related Lung Disease Among Flavor Manufacturing Workers in California 08/07

http://www.cdph.ca.gov/programs/ohb/Documents/flavor-guidelines.pdf 6. National Lung Health Education Program (NLHEP) http://www.nlhep.org/ 7. 3M Regulations Handbook (Fifth Edition – 2006): Respiratory Protection:

http://multimedia.mmm.com/mws/mediawebserver.dyn?6666660Zjcf6lVs6EVs666NEBCOrrrrQ-

8. NIOSH Publications: 1-800-35-NIOSH; http://www.cdc.gov/niosh/pubs.html NIOSH Respirator Decision Logic 2004 http://www.cdc.gov/niosh/docs/2005-100/default.html

NIOSH Approved Courses: http://www.cdc.gov/niosh/topics/spirometry/training.html NIOSH Spirometry Training Guide: http://www.cdc.gov/niosh/docs/2004-154c/pdfs/2004-154c.pdf Program Administrator: [email protected] B Reader List (Print): 304-285-5724; On-line: http://www.cdc.gov/niosh/topics/chestradiography/breader-list.html

ILO X-Ray Reading Form: http://www.cdc.gov/niosh/topics/surveillance/ords/pdfs/CWHSP-ReadingForm-2.8.pdf 9. OSHA Publications (national office): 202-693-1888

OSHA Medical Surveillance webpage: http://osha.gov/SLTC/medicalsurveillance/index.html OSHA Respiratory Protection eTool: http://www.osha.gov/SLTC/etools/respiratory/index.html

10. International Labor Organization Encyclopedia of Occupational Safety and Health, 4th edition (no charge)

http://www.ilo.org/safework_bookshelf/english?d&nd=170000102&nh=0 11. ISO 26782:2009 Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced

expired volumes in humans. Available thorough American National Standards Institute (ANSI) at: http://webstore.ansi.org/RecordDetail.aspx?sku=ISO+26782%3A2009

12. Training, Consulting, and Quality Review Center for Spirometry: a collaborative effort of Bill Eschenbacher, M.D.,

John Hankinson, Ph.D., and Mary C. Townsend, Dr. P.H.: http://www.occspiro.com

SPIROMETRY IN THE OCCUPATIONAL SETTING REFERENCES

ACOEM Spirometry Statements 1. ACOEM Position Statement: Spirometry in the Occupational Setting. JOEM 2000; 42:228-245. 2. ACOEM Position Statement: Evaluating Pulmonary Function Change Over Time in the Occupational Setting. JOEM

2005; 47:1307-1316. (http://www.acoem.org/guidelines.aspx?id=756) 2/2/2004 ATS Statements 3. American Thoracic Society – European Respiratory Society: General Considerations for Lung Function Testing. Eur

Respir J: 26 (1): 153-161, 2005. http://www.thoracic.org/statements/resources/pfet/PFT1.pdf 4. American Thoracic Society – European Respiratory Society: Standardisation of spirometry. Eur Respir J: August 1,

2005; 26 (2): 319-338, 2005. http://www.thoracic.org/statements/resources/pfet/PFT2.pdf 5. American Thoracic Society – European Respiratory Society: Interpretative Strategies for Lung Function Tests. Eur

Respir J 2005; 26:948-968. http://www.thoracic.org/statements/resources/pfet/pft5.pdf


6. American Thoracic Society. Standardization of Spirometry: 1994 Update. Am J Resp Crit Care Med 152: 1107-1136, 1995. http://www.thoracic.org/statements/resources/archive/201.pdf

7. Lung Function Testing: Selection of Reference Values and Interpretative Strategies. Am Rev Resp Dis 144: 1202-1218, 1991. http://www.thoracic.org/statements/resources/archive/lft-1991.pdf

8. Respiratory Protection Guidelines. Am J Respir Crit Care Med 154:1153-1165, 1996. http://www.thoracic.org/statements/resources/eoh/resp1-13.pdf

9. Guidelines for the Evaluation of Impairment/Disability in Patients with Asthma. Am Rev Resp Dis 147: 1056-1061, 1993. http://www.thoracic.org/statements/resources/archive/503.pdf

10. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J 26: 720–735, 2005. http://www.thoracic.org/statements/resources/pfet/pft4.pdf

11. Guidelines for Methacholine and Exercise Challenge Testing - 1999. Am J Respir Crit Care Med 161:309-329, 2000. http://www.thoracic.org/statements/resources/pfet/methacholine1-21.pdf

12. Evaluation of Impairment/Disability Secondary to Respiratory Disorders. Am Rev Resp Dis 133: 1205-1209, 1986. Books: 13. Hyatt, RE, Scanlon, PD, Nakamura, M. Interpretation of Pulmonary Function Tests: A Practical Guide, Second

Edition, Lippincott Wlliams & Wilkins, Philadelphia, 2003. 14. Morris AH, Kanner RE, Crapo RO, Gardner RM: Clinical pulmonary function testing: a manual of uniform laboratory

testing procedures, 2nd edition. Intermountain Thoracic Society, Salt Lake City, UT, 1984. 15. McLellan RK and Schusler KM: Guide to the Medical Evaluation for Respirator Use. Beverly Farms, MA, OEM

Press, 2000. (http://www.oempress.com/) Infection Control: 16. Hiebert T, Miles J, and Okeson GC: Contaminated aerosol recovery from pulmonary function testing equipment. Am J

Respir Crit Care Med 159: 610-612, 1999. 17. Kendrick AH, Smith EC, and Leeming JP: Bacterial colonization as a potential source of nosocomial respiratory

infections in spirometers. Eur Respir J 10:1694-1695, 1997. 18. Leeming JP, Pryce-Roberts DM, Kendrick AH, et al: The efficacy of filters used in respiratory function apparatus. J

Hosp Infect 31:205-210, 1995. 19. Rutala DR, Rutala WA, Weber DJ et al: Infection risks associated with spirometry. Infect Control Hosp Epidemiol

12:89-92, 1991. Spirometry and Instrumentation: 20. Townsend MC: Technique And Equipment Pitfalls in Spirometry Testing: Serious Threats to Your Respiratory

Surveillance Program. NORA Medical Surveillance Workshop, Nov. 8, 2001. http://www.cdc.gov/niosh/topics/spirometry/pdfs/townsendhandout.pdf

21. Townsend MC, Hankinson JL, Lindesmith LA, Slivka, WA, Stiver, G, and Ayres GT. Is my lung function really that good? Flow-type spirometer problems that elevate test results. Chest 2004; 125:1902–1909. http://www.chestjournal.org/cgi/reprint/125/5/1902.pdf

22. Hankinson JL. Instrumentation for spirometry. Occup Med: State of the Art Reviews 8(2): 397-407, 1993. 23. Hankinson, JL. Beyond the Peak Flow Meter: Newer technologies for determining and documenting changes in lung

function in the workplace. Occup Med: State of the Art Reviews, 2000, In press. 24. Nelson SB, Gardner RM, Crapo RO et al: Performance evaluation of contemporary spirometers. Chest 97:288-297,

1990. 25. Hankinson JL and Wagner GR: Medical screening using periodic spirometry for detection of chronic lung disease.

Occ Med: State of the Art Rev 8(2): 353-361, 1993. 26. Enright PL: Surveillance for lung disease: Quality assurance using computers and a team approach. Occ Med: State of

the Art Rev 7(2): 209-225, 1992. 27. Hankinson JL, Castellan RM, Kinsley KB, and Keimig DG: Effect of Spirometer Temperature on Measurement of

FEV1 Shift Changes. JOM 28(12):1222-1225, 1986. 28. Hankinson JL: Pulmonary Function Testing in the Screening of Workers: Guidelines for Instrumentation,

Performance, and Interpretation. JOM 28(10): 1081-1092, 1986. Prediction Equations:


29. Crapo RO, Morris AH, Gardner RM: Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Resp Dis 123: 659-654, 1981.

30. Knudson RJ, Lebowitz MD, Holberg CJ, et al: Changes in the Normal Maximal Expiratory Flow-Volume Curve with Growth and Aging. Am Rev Resp Dis 127: 725-734, 1983.

31. Knudson RJ, Slatin RC, Lebowitz MD, et al: The maximal expiratory flow-volume curve: Normal standards, variability, and effects of age. Am Rev Resp Dis 113: 587-600, 1976.

32. Hankinson JL, Odencrantz JR, Fedan KB: Spirometric reference values from a sample of the general U.S. population. Am J Resp Crit Care Med 159:179-187, 1999. (http://ajrccm.atsjournals.org/cgi/reprint/159/1/179.pdf)

NFPA Recommendations: 33. National Fire Protection Association. NFPA 1582: Standard on Comprehensive Occupational Medical Program for Fire

Departments, 2007 Edition. National Fire Protection Association, Quincy, MA, 2007. 1-800-344-3555 http://webstore.ansi.org/RecordDetail.aspx?sku=NFPA+1582-2007&source=google&adgroup=nfpa&keyword=nfpa%201582&gclid=CKKEgMfF7Z8CFd1L5QodR33Sfg

COPD References National Lung Health Education Program (NLHEP) 34. Ferguson GT, Enright PL, Buist AS, and Higgins MW: Office Spirometry for Lung Health Assessment in Adults: A

Consensus Statement From the National Lung Health Education Program (NLHEP). CHEST 117:1146-1161, 2000. http://www.chestjournal.org/cgi/reprint/117/4/1146.pdf

35. “Simple Office Spirometry for Primary Care Practitioners”, http://www.nlhep.org/resources.html#phys Global Initiative for Chronic Obstructive Lung Disease (GOLD) 36. Pauwels RA, Buist AS, Calverley PMA, Jenkins CR, and Hurd SS: Global Strategy for the Diagnosis, Management,

and Prevention of Chronic Obstructive Pulmonary Disease: NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD). Am J Respir Crit Care Med 163: 1256-1276, 2001. http://ajrccm.atsjournals.org/cgi/reprint/163/5/1256.pdf

37. GOLD Workshop Report (updated 2008) http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989 38. GOLD Executive Summary (updated 2008) http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=996 39. GOLD Pocket Guide (updated 2008) http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=1116 40. Spirometry for Health Care Providers http://www.goldcopd.com/OtherResourcesItem.asp?l1=2&l2=2&intId=1836 Occupational Asthma & Serial Peak Flow Measurements: 41. Burge PS: Use of serial measurements of peak flow in the diagnosis of occupational asthma. Occupational Medicine:

State of the Art Reviews 8(2): 279-294, 1993. 42. American College of Chest Physicians Consensus Statement: Diagnosis and Management of Work-Related Asthma.

Chest 2008;134;1S-41S (http://chestjournal.chestpubs.org/content/134/3_suppl/1S.full.pdf) 43. Bernstein IL, Chang-Yeung M, Malo J-L, et al, editors: Asthma in the Workplace, 2nd Edition, New York, 1999,

Marcel Dekker, Inc. 44. Tarlo SM, Liss GM. Occupational asthma: an approach to diagnosis and management. CMAJ 168(7):867-871; 2003.

http://www.cmaj.ca/cgi/content/full/168/7/867 45. Chan-Yeung M, Malo J-L. Occupational Asthma. NEJM 333(2):107-112; 1995. National Asthma Education and Prevention Program (NAEPP) 46. USDHHS, PHS, NIH, NHLBI: National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3

(EPR3): Guidelines for the Diagnosis and Management of Asthma 2007, NIH Publication No. 08-4051. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

Global Initiative for Asthma (GINA) http://www.ginasthma.com/ 47. GINA Workshop Report, Global Strategy for Asthma Management and Prevention, Updated December 2007

http://www.ginasthma.com/Guidelineitem.asp??l1=2&l2=1&intId=60 48. Pocket Guide for Asthma Management and Prevention - updated December 2006

http://www.ginasthma.com/Guidelineitem.asp??l1=2&l2=1&intId=37 49. Asthma Management and Prevention: A Practical Guide - 1996

http://www.ginasthma.com/GuidelineItem.asp?intId=819

Medical Surveillance for Flavor Manufacturing Workers August 2007

Hazard Evaluation System and Information Service ● Occupational Health Branch ● California Department of Public Health

15

Appendix B: Spirometry Quality Guidelines Spirometry testing standards

• Equipment: o Written verification from a third party (not the manufacturer or distributor)

that the spirometer has successfully passed its validation checks using the most current ATS protocol. The manufacturer may be able to provide a copy of the letter from an independent testing laboratory detailing the validation results for the specific model of spirometer being used.

o Spirometer must store and print all results from the best three acceptable

maneuvers, including volume‐time and flow‐volume curves.

• Spirometry Technician: o Should have successfully completed a NIOSH‐approved spirometry training

course (http://www.cdc.gov/niosh/topics/spirometry/) within the previous five years or should be certified by the National Board for Respiratory Care as a Certified Pulmonary Function Technologist (CPFT). Copies of certificates of completion of a NIOSH‐approved spirometry training course and/or CPFT certification should be maintained.

o Spirometry reports should be periodically reviewed for quality and should

demonstrate that at least 80% of tests completed by each technician have three acceptable maneuvers with two maneuvers within ATS repeatability criteria.

• Testing Procedures:

o Spirometer calibration checks should be performed using a currently calibrated (per manufacturer recommendations) three‐liter syringe on each day of testing (6). A copy of the spirometer calibration report should be maintained either electronically or in hard copy form.

o Spirometry should be performed in the same documented position (either

sitting or standing) during the baseline and all subsequent tests.

o A minimum of three forced exhalation maneuvers producing “Acceptable Curves” on the spirometry report should be characterized by:

Lack of hesitation (back‐extrapolation volume should be less than five percent of FVC or 150 mL, whichever is larger);

Free of cough in the first second; No evidence of airflow cessation, variable effort, leak, obstructed

mouthpiece, or extra breath(s);



16

At least six seconds in duration; and Meeting acceptable end‐of‐test criteria (< 25 mL increase in volume

for one second or a maneuver greater than 15 seconds in duration).

o Less than 150 mL difference between the two highest FVC measurements and the two highest FEV1 measurements is the goal.

o Spirometry report should include:

Spirometry values and volume‐time and flow‐volume curves for the three best blows;

Reference values used; Date of last calibration check; Initials or name of the technician; and Name of the company.

Spirometry Predicted Values

If spirometry software allows a choice of predicted values, NHANES III should be used (7). NHANES III predicted values are recommended by ATS and are based on a much larger population, compared to other studies. NHANES III predicted values are not available for Asians. Predicted values for Asians born in the United States can be calculated by multiplying the NHANES III Caucasian predicted values for FEV1 and FVC by 0.94 (8). If spirometry software does not include lower limits of normal values, the Web link http://www.cdc.gov/niosh/topics/spirometry/RefCalculator.html can be used to calculate lower limits of normal for NHANES III reference values. Be aware that all predicted values and lower limit of normals should be from the same reference paper.



17

Appendix C: Scoring Criteria for Spirometry Test Quality Using the definition of “Acceptable Curves” described earlier in Spirometry Quality Guidelines (Appendix B), the following quality codes should be used. FEV1 Quality Codes Grade A: At least three acceptable curves, repeatable within

• 50 mL if FEV1 is derived from the last curve • 100 mL otherwise

Grade B: At least two acceptable curves, repeatable within 150 mL Grade C: At least two acceptable curves, repeatable within 250 mL Grade D: Only one acceptable curve Grade F: No acceptable curve FVC Quality Codes Grade A: At least three acceptable curves,

• If best FVC derived from last curve, repeatability within 50 mL; otherwise, FVC repeatable within 100 mL

• FVC acceptable curve demonstrates o Greater than six second exhalation o Achievement of exhalation volume plateau

Grade B: At least two acceptable curves,

• FVC acceptable curve requirements o Greater than six second exhalation o Achievement of exhalation volume plateau

• FVC repeatability within 150 mL

Grade C: At least two acceptable curves, • FVC acceptable curve requirements are greater than six second

exhalation ONLY. (Plateau is not required.) • FVC repeatability within 250 mL

Grade D: Only one acceptable curve Grade F: No acceptable curves

RespiratoryProtection —Respirator Use

PhysicalQualificationsfor Personnel

ANSI/AIHA Z88.6–2006

A Publication byAmerican Industrial Hygiene Association

®

American National Standard

for

Reprinted with permission of the American Industrial Hygiene Association (2010).

ANSI/AIHA Z88.6—2006

American National Standardfor Respiratory Protection —

Respirator Use —Physical Qualifications for Personnel

Approved: August 25, 2006

American Industrial Hygiene Association


AmericanNationalStandard

Approval of an American National Standard requires verification by ANSI thatthe requirement for due process, consensus, and other criteria for approvalhave been met by the standard’s developer.

Consensus is established when, in the judgment of the ANSI Board ofStandards Review, substantial agreement has been reached by directly andmaterially affected interests. Substantial agreement means much more than asimple majority, but not necessarily unanimity. Consensus requires that allviews and objection be considered, and that a concerted effort be madetoward their resolution.

The use of American National Standards is completely voluntary; their exis-tence does not in any respect preclude anyone, whether he or she hasapproved the Standards, or not, from manufacturing, marketing, purchasing, orusing products, processors, or procedures not conforming to the Standards.

The American National Standards Institute does not develop standards andwill in no circumstances give an interpretation of any American NationalStandard. Moreover, no person shall have the right or authority to issue aninterpretation of an American National Standard in the name of the AmericanNational Standards Institute. Requests for interpretations should be addressedto the secretariat or sponsor whose name appears on the title page of thisstandard.

CAUTION NOTICE: This American National Standard may be revised or with-drawn at any time. The procedures of the American National StandardsInstitute require that action be taken to reaffirm, revise, or withdraw thisStandard no later than five years from the date of approval. Purchasers ofAmerican National Standards may receive current information on all standardsby calling or writing the American National Standards Institute.

Published byAmerican Industrial Hygiene Association2700 Prosperity Ave., Suite 250Fairfax, VA 22031www.aiha.org

Copyright © 2006 by the American Industrial Hygiene AssociationAll rights reserved.

No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher.

Printed in the United States of America.

Stock No: SRPA06-716ISBN: 1-931504-71-7


ContentsPage

Foreword .....................................................................................................................................iiiSubcommittee Members..............................................................................................................v

1 Scope and Purpose.....................................................................................................................1 1.1 Scope.................................................................................................................................11.2 Purpose .............................................................................................................................11.3 “Shall” and “Should” ...........................................................................................................11.4 Exceptions .........................................................................................................................1

2 Normative References.................................................................................................................1

3 Definitions....................................................................................................................................1

4 Respirator Characteristics ...........................................................................................................3

5 Medical Evaluation Rationale ......................................................................................................4

6 Qualification of Persons Who Conduct Medical Evaluations to Determine Suitability to Use Respiratory Protective Devices............................................................................................4

7 Evaluation Requirements ............................................................................................................4

8 Medical History............................................................................................................................5

9 Medical Evaluation ......................................................................................................................69.1 Frequency ..........................................................................................................................69.2 General Considerations .....................................................................................................6

10 Special Testing.............................................................................................................................810.1 Spirometry .........................................................................................................................8

AnnexesAnnex A Exercise Stress Testing ............................................................................................9Annex B1 Respirator Medical Examination Form/Temporary Disqualification Criteria...........11Annex B2 Request for Medical Clearance for Respirator Use Questionnaire

PLHCP Determination of Class Form....................................................................12Annex B3 Example of the Medical Questionnaire for Respirator Users Initial Form..............13Annex B4 Example of the Medical Questionnaire for Respirator Users Periodic Form .........15Annex B5 Example of Employee Copy of PLHCP’s Written Communication Form ...............16Annex C Spirometry (Guidance for Performance and Interpretation)...................................17Annex D Future Research Areas..........................................................................................19


iii


FOREWORD

A series of related American National Standards were identified after the development of ANSIZ88.2–1980 “Respiratory Protection Programs” to address specialized technical elements of respi-ratory protection programs. ANSI Z88.6–1984 “Respirator Use — Physical Qualifications forPersonnel” was the first of these standards to be developed. ANSI/AIHA Z88.10–2001 “RespiratorFit Testing Methods” has also been developed and is available to provide detailed respiratory pro-tection program guidance in the area of respirator fit testing.

American National Standard Z88.6-1984 contained general, rather than specific requirementsbecause it was the first standard to deal with this subject. It was intended that “more specificrequirements” would be provided in future editions that would provide more detailed guidance toassist medical professionals in determining which individuals should and should not be medicallyqualified to wear respirators. Annex C of the 1984 standard concluded with suggested “Areas ofFuture Investigation.” This standard addresses these and other areas and presents a process thatmeets, and in many areas exceeds, the minimum requirements of the Occupational Safety andHealth Administration’s (“OSHA”) Respiratory Protection Standard (the “federal standard”) 29 CFR1910.134, and:

• Includes all the questions required by the OSHA respirator questionnaire as well as additionalquestions to assess the risk of cardiac disease,

• Recommends physician review of all cases that fall outside certain parameters, and• Considers the physiologic demand of the type of work to be performed, and type of respirator for

which approval is granted.

The Committee has made the following determinations regarding the revised Standard:

• Any medical professional authorized to evaluate respirator use should be required to know thephysiologic demands associated with various types of respirators.

• The impact of safe and reliable work performance on fellow workers and the public should beconsidered.

• The impact of medical factors on job performance exclusive of respirator use should be considered.• Conditional approval may be granted in appropriate cases.• A periodic medical questionnaire prior to annual respirator fit testing should be administered.• Clinical Exercise Stress Testing (EST) is a useful test for evaluating the functional capacity (work

capacity) of users of industrial respirators as respiratory reserve is normally greater than circulatorysystem reserve and cardiac disease is more common as a disqualifier than pulmonary disease.

• The routine use of spirometry to determine the suitability of individuals to use respiratory protectivedevices is not required, although pulmonary function data (especially aggregate data) may be animportant measure of response to worker exposure.

• Workers are less likely to have clinically significant Coronary Artery Disease “CAD” and to beheat intolerant if they achieve a negative EST to 10 METs.

• Specific blood pressure, body weight, and pulmonary function values will require physician con-sideration, and/or evaluation, and/or medical testing.

• The conservative definition of “heavy” work as suggested by “OSHA” should be adopted.• A concise statement regarding facial hair should be included. • Workers using contact lenses, and workers with perforated tympanic membranes should not be

routinely excluded.• A chest X-ray should not be used routinely to determine suitability to use respirators.• Spirometry should be interpreted in accordance with the recommendations of the American

Thoracic Society (ATS) and that ATS recommendations for performing spirometry tests should beconsidered as useful guidance by evaluators.


iv


There are four annexes in this standard. These annexes are informative and are not consideredpart of the standard. Suggestions for the improvement of this standard will be welcome. Theyshould be sent to the ANSI Z88 Secretariat, American Industrial Hygiene Association, 2700Prosperity Avenue, Suite 250, Fairfax VA. 22031.

Future revisions are anticipated to provide even more detailed guidance, especially as it applies toworkers with known serious medical issues.


v


This standard was processed and approved for submittal to ANSI by the Z88 Accredited StandardsCommittee on Respiratory Protection. Committee approval of the Standard does not necessarilyimply that all committee members voted for its approval. At the time it approved this Standard theZ88 Committee had the following members:

James S. Johnson, PhD, CIH, QEP, ChairStephen C. Graham, CIH, CSP, Vice ChairMili Mavely, Secretariat Representative

Organization Represented Name of RepresentativeAmerican Industrial Hygiene Association C. ColtonAmerican Iron and Steel Institute P. HernandezAmerican Society of Safety Engineers R. HarleyAmerican Welding Society S. HedrickBWXT, Y-12 M. HaskewCon Edison of New York G. SlintakEG&G Group R. MetzlerFord Motor Company S. MingelaHealth Physics Society H. CemberInternational Association of Firefighters R. DuffyInternational Brotherhood of Boilermakers D. HaggertyInternational Safety Equipment Association J. Comer BradleyLawrence Livermore National Laboratory J. JohnsonLos Alamos National Laboratory B. ReinertNational Fire Protection Association B. TeeleNational Institute of Occupational Safety and Health R. Berry AnnNational Park Service J. SahmelNavy Environmental Health Center D. SpelcePeach Bottom Atomic Power Station E. GeeUniversity of Cincinnati Medical Center R. McKayUniversity of Pittsburgh J. SchwerhaU.S. Department of Energy D. MarsickU.S. Department of Labor J. SteelnackU.S. Department of the Army S. Graham

Individual MembersC. BienD. BevisT. Nelson

At the time it approved this standard, the Z88 Committee had the following alternate members:

Organization Represented Name of Alternate RepresentativeInternational Safety Equipment Association J. BirknerNIOSH M. D’AlessandroU.S. Department of Energy D. WeitzmanU.S. Department of the Army I. Richardson


vi


The Z88.6 Subcommittee on Respirator Use – Physical Qualification for Personnel, which devel-oped this Standard, had the following members:

Ronald J. Mack M.D., MPH, ChairRoss L. Clay, MD, MPH Robert K. McLellan. MD, MPHWilliam Dyson, PhD, CIH Roy T. Mc Kay, PhDRichard Enkeboll Richard R. Reilly, PhDConnie R. Freiberg, CSP James P. Seward, PhDAndrew Jackson Mary C. Townsend, DrPHCharles P. Lisa, MD Patrick WesterkampMichael G. Maroldo


1

1 Scope and Purpose

1.1 Scope. This standard provides informationthat is useful for the medical evaluation ofrespirator users. This standard does notdeal with medical surveillance or biologi-cal exposure monitoring. It is understoodthat local circumstances vary, that no setof guidelines can cover all situations, andthat specific programs and proceduresshould be modified for each individualworkplace. Medical evaluation is only oneelement of a complete respiratory protec-tion program. A complete respiratory pro-tection program is defined in ANSIZ88.2–1992.

1.2 Purpose. This standard provides informa-tion and guidance to physicians or otherlicensed health care professionals(PLHCPs) to assist them in determiningthe medical suitability of personnel for res-pirator use. It identifies the responsibilityof management to provide the PLHCPwith supplemental information before thePLHCP makes a recommendation con-cerning an employee’s ability to use a res-pirator (see Section 7.1 of this Standard).Evaluators shall use their clinical judgmentin the application of these guidelines andrequire additional information or evalua-tion as necessary to permit certification orclassification for respirator use.

1.3 “Shall” and “Should.” The provisions ofthis standard are mandatory in naturewhere the word “shall” is used and advi-sory in nature where the word “should” isused.

1.4 Exceptions. Users of this standardshould be aware that regulatory agenciesmay have requirements that are differentfrom this standard.

2 Normative References. The followingstandards contain provisions which,through reference in this text, constituteprovisions of this American NationalStandard. At the time of publication, theeditions indicated were valid. All stan-dards are subject to revision, and partiesto agreements based on this AmericanNational Standard are encouraged toinvestigate the possibility of applying themost recent editions of the standardsindicated below.

ANSI Z88.2–1992, American NationalStandard for Respiratory Protection

ANSI Z88.6–1984, RespiratoryProtection–Respirator Use — PhysicalQualifications for Personnel

ANSI/AIHA Z88.10–2001- Respirator Fit TestMethods

3 Definitions

3.1 Body mass index (BMI): A measure-ment used to assess weight, relative toheight. BMI is calculated by dividing bodyweight in kilograms by height in meterssquared (kg/m2).

3.2 Canister or cartridge: A container witha filter, sorbent, or catalyst, or combina-tion of these items, which removes spe-cific contaminants from the air passedthrough the container.

3.3 Emergency situation: Any occurrencesuch as, but not limited to, equipmentfailure, rupture of containers, or failure ofcontrol equipment that may, or does,result in an uncontrolled significantrelease of an airborne contaminant.

3.4 Employee exposure: An exposure to aconcentration of an airborne contaminant

American National Standard for Respiratory Protection —Respirator Use —Physical Qualifications for Personnel

AMERICAN NATIONAL STANDARD ANSI Z88.6—2006


2

that would occur if the employee werenot using respiratory protection.

3.5 End-of-service-life indicator: A systemthat warns the user of the approach thatthe end of adequate respiratory protec-tion is imminent.

3.6 Escape-only respirator: A respiratorintended only for use during emergencyegress from a hazardous atmosphere.

3.7 Exercise stress test (EST): A standardgraded exercise test used to assess anindividual’s ability to tolerate increasingintensities of exercise while electrocar-diographic (EKG), hemodynamic, andsymptomatic responses are monitoredfor manifestations of ischemia, electricalinstability, or other exertion-relatedabnormalities.

3.8 Filter: A component used in respiratorsto remove solid or liquid aerosols fromthe inspired air.

3.9 Filtering facepiece: A negative-pressurerespirator with an air-purifying elementas an integral part of the facepiece orwith the entire facepiece composed ofthe air-purifying medium.

3.10 Fit factor: A numeric estimate of howwell a tight-fitting respirator facepiece fitsan individual during a quantitative fit test.It is the ratio of the concentration outsidethe facepiece (C out) to the concentrationinside the facepiece (C in). (Fit factor = C out/C in ).

3.11 Fit test: The use of a challenge agent toevaluate an individual’s ability to obtain anadequate seal with a specific respirator.

3.12 Helmet: A hood that offers head protec-tion against impact and penetration.

3.13 Hood: A respiratory inlet covering thatcompletely covers the head and neckand may cover portions of the shoulders.

3.14 Immediately dangerous to life andhealth (IDLH): Any atmosphere thatposes an immediate hazard to life orposes immediate irreversible debilitatingeffects on health.

3.15 Interior structural firefighting: Thephysical activity of fire suppression, res-cue or both, inside of buildings orenclosed structures which are involved ina fire situation beyond the incipient state(See 29 CFR 1910.155).

3.16 Loose-fitting facepiece: A respiratoryinlet covering that is designed to form apartial seal with the face, does not coverthe neck and shoulders, and may or maynot offer head protection against impactand penetration.

3.17 Metabolic equivalents (METs): A unit ofenergy expended: one MET is 3.5 mL 02 /kg/min and represents the energyexpended at rest. Standardized exerciseprotocols express energy expended interms of multiples of resting metabolicenergy or METs.

3.18 Negative pressure respirator: A respi-rator in which the air pressure inside therespiratory inlet covering is negative dur-ing inhalation with respect to the ambientair pressure.

3.19 Oxygen deficient atmosphere: An oxy-gen partial pressure of 96 to 122 mmHgshall be considered an oxygen-deficientatmosphere that is not immediately dan-gerous to life (IDLH). An oxygen partialpressure of 95 mmHg or less shall beconsidered IDLH. The oxygen deficiencymay be caused by a reduction in the nor-mal 20.9% oxygen content, by reducedtotal atmospheric pressure, or by anycombination of reduced percentage ofoxygen and reduced pressure.

3.20 Physician or other licensed healthcare professional (PLHCP): An individ-ual whose legally permitted scope ofpractice (i.e., license, registration, or cer-tification under state law) allows him orher to independently provide, or be dele-gated the responsibility to provide, someor all of the health care services requiredby paragraph (e) of 29 CFR 1910.134.

3.21 Positive pressure respirator: A respira-tor in which the pressure inside the respi-ratory inlet covering is normally positivewith respect to ambient air pressure.



3

3.22 Qualitative fit test (QLFT): A pass/failtest that relies on the subject’s sensoryresponse to detect the challenge agent.

3.23 Quantitative fit test (QNFT): A fit testthat uses an instrument to measure thechallenge agent inside and outside therespirator.

3.24 Respiratory inlet covering: The portionof a respirator that connects the wearer’srespiratory tract to an air-purifying deviceor respirable gas source, or both. It maybe a facepiece, helmet, hood, suit, ormouthpiece/nose clamp.

3.25 Self-contained breathing apparatus(SCBA): An atmosphere supplying respi-rator in which the respirable gas sourceis designed to be carried by the user.

3.26 Service life: The period of time that arespirator provides adequate protectionto the wearer.

3.27 Tight-fitting facepiece: A respiratoryinlet covering that is designed to form acomplete seal with the face. A half-face-piece (includes quarter masks, filteringfacepieces, and masks with elastomericfacepieces) covers the nose and mouth;a full facepiece covers the nose, mouth,and eyes.

3.28 User seal check: A procedure conduct-ed by the wearer to determine if the res-pirator is properly sealed to the face.

4 Respirator Characteristics

4.1 Air-Purifying Respirators

4.1.1 General. Air-Purifying Respirators (APR)remove specific air contaminants bypassing ambient air through an air-purify-ing filter, cartridge, or canister. APR areeither non-powered or powered. APR arenot approved for fire-fighting efforts.

4.1.2 Air-purifying (nonpowered) respira-tors: Inhalation through the filteringmedia and exhalation through the valvedepend only on the breathing action ofthe lungs. Inhalation resistances are lessthan 35mm H20 and exhalation resist-ances are less than 25 mm H20.

4.1.3 Powered air-purifying respirators(PAPR): Powered units contain a blowerto move the air through the filtering media.Inhalation and exhalation resistance isnegligible, similar to a continuous-flow air-line device. The weight of the blowervaries from approximately 5 to 15 lb.

4.2 Atmosphere-Supplying Respirators

4.2.1 General. Atmosphere-supplying respira-tors are either self-contained or airlineunits. The self-contained breathing appa-ratus (SCBA) is completely portable. Theairline apparatus requires the trailing ofan air hose from the wearer to thesource of breathing air.

Atmosphere-supplying respirators oper-ate in continuous- flow, demand, or pres-sure-demand modes. Continuous-flowrespirators blow air continuously into themask. Demand-type apparatus requirethe wearer to inhale and reduce themask pressure below atmospheric pres-sure, before the regulator will supply air.(This is similar to inhaling through an air-purifying device). In a pressure-demand(positive-pressure) device, a slight posi-tive pressure is maintained in the face-piece at all times by the regulator. Moreair is admitted to the mask as the posi-tive pressure decreases during inhala-tion. Exhalation resistances are greaterthan for demand devices.

4.2.2 Open-circuit SCBA. Open-circuit SCBAis available in demand or pressure-demand devices. In open-circuit devices,breathing air is supplied from a cylinder tothe mask, and then dumped into theatmosphere on exhalation. The nitrogen inthe breathing air is excess weight thatdoes not contribute to the wearer’s metab-olism. The maximum allowed weight is 35lb, although modern half-hour units mayweigh 10 lb less. Significant reduction (upto 20%) in work capacity of the wearercan occur since the 35 lb load must becarried. Heavy work rates may berequired during fire-fighting and rescue sit-uations while wearing SCBA.

Regulators on current SCBA may notmeet the high instantaneous demands ofwearers at heavy work rates, and so may



4

impair work out-put further. Theincreased exhalation resistance of pres-sure-demand units may also degradeability to perform heavy work.

4.2.3 Closed-circuit SCBA. Closed-circuitSCBA is available in demand or pres-sure-demand devices. In closed-circuitunits (also known as rebreathers), oxy-gen is supplied from a compressed gas,liquid, or chemical source. Exhaled air isscrubbed of carbon dioxide and returnedto the facepiece. Closed-circuit deviceshave a longer duration for their weightthan does open-circuit equipment.Breathing is into and out of a bag ratherthan from a regulator. Oxygen concentra-tions may range from 21 to 90 percent.

4.2.4 Supplied-air respirators (SAR).Supplied-air or airline respirators areavailable as continuous-flow, demand, orpressure-demand devices. All suppliedair respirators require a trailing air hosethat limits movement about the work-place. Duration of use is limited only bythe air source and the metabolic workrate. Exhalation resistance is equal to orlower than that of demand equipment,since the exhalation valve is held openby the continuous outward flow of air.Demand and pressure-demand versionsof airline units have physiological effectssimilar to the SCBA, except for the addi-tional weight burden of the SCBA.

5 Medical Evaluation RationaleThe effects of physical work effort, pro-tective clothing, temperature, humidity,and the physiologic burden placed on aworker using a respirator must be con-sidered during the medical evaluation forrespirator use. PLHCPs shall providereasonable assurance that a worker canendure these stressors without adversemedical consequences, and recommendany limitations on respirator use relatedto the medical condition of the employeeor the work place conditions in which therespirator will be used.

6 Qualifications of Persons WhoConduct Medical Evaluations toDetermine Suitability to UseRespiratory Protective Devices

6.1 Medical evaluation shall be performed bya physician or other licensed health careprofessional (LHCP) (e.g., nurse practi-tioner, physician assistant, occupationalhealth nurse), provided that their licensepermits them to perform such evalua-tions. LHCPs are expected to consultwith an appropriate physician whenquestions arise about an employee’sphysical condition and capability, such asthose described in this standard.

7 Evaluation Requirements

7.1 The industrial hygienist, safety profes-sional, or other employer representativeshall provide the PLHCP with supple-mental information before the PLHCPmakes a recommendation concerning anemployee’s ability to use a respirator. Thefollowing supplemental information shallbe provided (see Annex B2):(a) The type and weight of the respira-

tor to be used by the employee.This should include (i) effort ofbreathing, (ii) special features,such as size, shape, bulk, full face,hood, etc.

(b) The duration and frequency of res-pirator use (including use for res-cue and escape);

(c) The expected physical work effort;(d) Additional protective clothing and

equipment to be worn; (e) Temperature and humidity

extremes that may be encoun-tered;

(f) A copy of the written respiratoryprotection program; and,

(g) A copy of 29 CFR Part 1910.134 –Respiratory Protection; Final Rule.

7.1.1 Extent of usage should be defined asfollows:(1) On a daily basis (if so, state maxi-

mum hours a day of expected use).(2) Occasionally, but probably more

than once weekly (as in mainte-nance worker), if so state maxi-mum hours per week of expecteduse.

(3) Rarely (if so state maximum hoursper year of expected use).

(4) For emergency situations only.



5

7.1.2 Special responsibilities should bedefined, such as, individuals who haveresponsibility for the safety of others andconsequently may be expected to havespecial physical capabilities. This wouldinclude rescue workers, fire fighters,security personnel, and the like.

7.1.3 The estimated frequency for each type of“emergency situation” that may pose anIDLH risk, should be provided.

7.1.4 Other special environmental conditions(i.e., excessive heat, confined spaceusage, hyperbaric or hypobaric environ-ments) should be identified. Additionalrequirements for protective clothingshould also be listed.

7.1.5 The above supplemental informationneed not be provided for subsequentmedical evaluations if the informationremains the same and is transferred tothe new evaluator.

7.1.6 The agents to which a worker will beexposed should be identified for regularlyscheduled work and during emergencieswhen possible.

7.2 Based on this medical evaluation and theinformation provided, the PLHCP shallcertify whether the individual is permittedto use a respirator under the circum-stances described. The physicaldemands of the work shall be the limitingfactor. The special characteristics of therespirator(s) to be used for this work, inso far as they significantly increase thework demands while in use, shall be considered.

7.2.1 In addition to the classification for respi-rator use, the report to the employer rep-resentative should include any otherwork limitations or restrictions found dur-ing evaluation even if they are not neces-sarily related specifically to respiratoruse.

7.2.2 The PLHCP shall classify the examineein a category as follows (see Annex B2).(1) Class 1: No restriction on respira-

tor use.(2) Class 2: Conditional respirator use

permitted, subject to specific use

restrictions, medical evaluations, ortreatments. These work restrictionsshould be identified to permit adecision by the supervisor or safetyrepresentative to determine suitabil-ity for a specific task. Restrictionsmay include moderate/light workonly, no SCBA use, PAPR only,annual medical evaluation orage–specific medical evaluation.

(3) Class 3: Permanent restriction fromrespirator use. No respirator usepermitted (permanent) under anycircumstances. The reason shouldnot be identified on the report tothe supervisor or to the safetydepartment or other groups respon-sible for the respirator program.

(4) Class 4: Temporary restriction fromrespirator use. No respirator usepermitted (temporary) — workerrequires additional medical evalua-tion and/or treatment and physicianevaluation.

(5) Class 5: Additional temporary orpermanent non-respirator workrestrictions (e.g., no heavy lifting,no climbing, no heat stress).

7.3 Written respirator program standardoperating procedures shall include a writ-ten procedure describing the medicalevaluation process for respirator users.

8 Medical History

8.1 A medical history (respirator question-naire) should be utilized to identify thefollowing (See Annex B3):(1) Previously diagnosed disease, par-

ticularly known cardiovascular orrespiratory diseases.

(2) Psychological problems or symp-toms including claustrophobia.

(3) Problems associated with breath-ing during normal work activities.

(4) Past problems with respirator use.(5) Past and current usage of medica-

tion.(6) Any known physical deformities or

abnormalities, including thosewhich may interfere with respiratoruse.

(7) Known current pregnancy.



6

8.2 The PLHCP shall review the medicalquestionnaire.

Conditions that may possibly disqualifypersonnel for respirator use as identifiedby a positive response on the respiratorquestionnaire must be followed by aninterview with a PLHCP.

If indicated, following an interview, thePLHCP shall refer or perform an evalua-tion of the individual (see Annex B1). ThePLHCP will determine the scope of theevaluation and what testing, if any, shallbe required to determine medical suit-ability to use a respirator.

In certain cases, following an evaluation,additional medical tests, consultation, ordiagnostic procedures (such as, a car-diac exercise stress test (EST), spirome-try, an audiogram, an ophthalmologyconsultation) may be necessary to makea final determination. Only the PLHCP’sdetermination shall be communicated tothe supervisor/manager (see Annex B2,Section B); no medical information shallbe communicated.

9 Medical Evaluation

9.1 Frequency. An initial medical evaluationshall be performed using a medical histo-ry (respirator questionnaire) or interviewand examination that obtain the sameinformation as the medical questionnaire.Additional evaluations shall be required if:a) the employee reports medical signs orsymptoms that are related to the ability touse a respirator; b) a PLHCP, supervisor,or the respirator program administratorinforms the employer that an employeeneeds to be reevaluated; c) informationfrom the respiratory protection programincluding observations made during fittesting and program evaluation indicatesa need for employee reevaluation, or, d) achange occurs in workplace conditions(e.g., physical work effort, protectiveclothing, temperature) that may result in asubstantial increase in the physiologicalburden placed on an employee.

9.1.1 In addition, a follow-up questionnaire orinterview should be used periodically toidentify medical conditions that develop

after the initial evaluation. This question-naire could be administered prior to anannual fit test (see Annex B4). The fre-quency of this follow-up could be age-specific (e.g., every 5 years up to age35), then every 2 years until age 45, andannually thereafter.

9.1.2 Annual evaluations for SCBA users of allages shall be required.

9.1.3 Following review of the periodic question-naire and/or interview, and/or limitedmedical testing, the PLHCP may deter-mine that certain individuals require addi-tional evaluation (such as, all or part ofthe physical examination and testingdescribed in Annex B1) and/or medicaltesting, consultation, or diagnostic proce-dures.

9.2 General Considerations. The PLHCP’sevaluation of suitability of the individualexaminee for respirator use shall bebased on the unique medical status of theindividual (in light of the work load to beperformed while wearing the respirator).

9.2.1 Following the initial or a subsequent eval-uation the PLHCP may determine thatperiodic medical re-evaluation (examina-tion, or testing, or consultation) is appro-priate for a certain individual.

The PLHCP shall provide the worker-employee and the employer with a writ-ten recommendation regarding the work-er’s medical ability to use a respirator(see Annex B2, Section B). The PLHCPshall also notify the worker-employee ofany medical conditions, actions recom-mended, and the frequency of necessaryperiodic-evaluations. (See Annex B5).

9.2.2 The following conditions shall be consid-ered temporarily disqualifying for mostrespirator use. These conditions mayrequire medical evaluation or treatmentand may result in permanent restrictionfrom respirator use. Additional communi-cation with the treating physician and/ora consultant physician, and monitoring ofhealth status may help to dispositionworkers with these conditions.(1) Facial deformities and facial hair or

other conditions that interfere with



7

proper sealing of the respirator (ifthe respirator has a face seal) shalldisqualify the applicant. A fit testshall not be conducted if there isany hair growth between the skinand the facepiece sealing surface,such as stubble beard growth,beard, mustache or sideburnswhich cross the respirator sealingsurface.

(2) Acute respiratory diseases whichare anticipated to resolve (includ-ing acute pneumonia, acute bron-chitis, and acute asthma) may pre-vent respirator use.

(3) “Moderate to severe” restrictive orobstructive pulmonary disease orperfusion disorders may require fur-ther evaluation. The worker’s med-ical history, physical examination,and spirometry results may beused as a basis for temporary dis-qualification pending further med-ical evaluation (see Annex B 1-Temporary Disqualification Criteria).Spirometry may also be useful formedical surveillance purposes withcertain workplace exposures.

(4) Symptomatic coronary artery dis-ease (CAD), significant arrhyth-mias, (e.g., premature ventricularcontractions (PVCs), tachycardia,or bradycardia), or a history ofmyocardial infarction may requirefurther evaluation. If an EKG isperformed it should be interpretedusing informed clinical judgmentwith consideration of the workersoverall health status.

(5) The determining physician, usingclinical judgment, shall decide ifindividuals with treated or untreat-ed hypertension, individuals usingcardiovascular medications, andindividuals with multiple risk factorsor a single extreme risk factorrequire further medical evaluation.

(6) Workers with a systolic blood pres-sure (S.B.P.) greater than or equalto 180 or a diastolic blood pressure(D.B.P.) greater than or equal to110 treated or untreated, shall betemporarily restricted from respira-tor use. Workers with a S.B.P.greater than or equal to 140 or a

D.B.P. greater than or equal to 90shall be referred for physician eval-uation. The evaluating physicianwill disposition the worker afterconsideration of the medical infor-mation provided and the workeffort anticipated.

(7) In cases where the evaluatingphysician has concerns about aworker’s ability to use respiratoryprotective devices due to abnormalpulmonary function testing, (seeSection 10.1 and Annex C), a his-tory of Coronary Artery Disease,obesity [body mass Index (BMI) ofgreater than 30], or a combinationof these or other medical prob-lems, the worker may be medicallycleared for respirator use at aknown level of work (light, moder-ate, heavy) by use of an ExerciseStress Test (EST). The demonstra-tion of greater than or equal to 10Metabolic Equivalents (METs)functional capacity absentischemia, arrhythmia, or abnormalBP response, on a physiciansupervised Exercise Stress Test(EST) — (See Section 10.1 andAnnex A) is considered adequatefor clearance to perform mostheavy physical work and to work inheat stress environments. (SeeAnnex B1.)

(8) Neurological Disability. Certainneurologic disorders that affectmovement and/or consciousnessmay be aggravated by the workenvironment associated with respi-rator use (heat, humidity, protectiveclothing, strenuous work). Workerswith such a disorder shall be tem-porarily disqualified pending physi-cian evaluation.

(9) Medications. PLHCPs shall useclinical judgment to determine if anindividual should be denied use ofa respirator due to medication use(including prescription and non-pre-scription drugs) that may affect anemployee’s ability to perform his orher job. This decision may involvecommunication with a treatingphysician or consultant physician.



8

(10) Psychological Conditions. ThePLHCP shall decide if an employ-ee with a psychological conditionthat may impair judgment or relia-bility should be disqualified (e.g.,claustrophobia, severe anxiety).The decision may involve commu-nication with the treating physician,or a consultant physician. ThePLHCP may recommend observedfit testing for the examinee.

(11) Hearing should be adequate toensure response to instructionsand alarm systems or hearing defi-ciencies should be otherwiseaccommodated. In certain workenvironments, olfaction may be animportant sense to warn respiratorusers of poor face seal or othercauses of respirator failure.Workers who report troublesmelling odors may require workrestriction or additional medicalevaluation (which may include

olfactory testing) and these work-ers may be unsuitable for fit testingmethods that rely on odor detec-tion. Workers shall have adequatevision to perform their assigned jobduties.

(12) If a worker has suffered a suddenloss of consciousness or responsecapability, a physician shall deter-mine if the employee may use arespirator.

10 Special Testing

10.1 Spirometry or Exercise Stress Testing(EST) may be used if the PLHCP needsinformation in addition to a history andphysical. Spirometry results do not inthemselves indicate fitness or lack of fit-ness to use a respirator For accurateassessment, spirometry should be per-formed in accordance with the mostrecent recommendations of the AmericanThoracic Society (See Annex C).



9


Annex A: Exercise Stress Testing

Clinical exercise testing, or the exercise stress test (E.S.T.), is a useful test for evaluating the func-tional capacity (work capacity) of users of industrial respirators as respiratory reserve is normallygreater than circulatory system reserve and cardiac disease is common in working populations.(1)

Cardiac disease is a common cause of sudden incapacity, and decreased functional capacity. Fornormal humans, it appears there is no single exercise-limiting factor; the heart with contributions ofmuscle, rather than lungs and blood is largely responsible for exercise limitations, training effects,and differences in exercise capacity between people.(2)

The EST is a convenient means of determining exercise tolerance and precipitating symptoms andsigns in a controlled environment. Standardized protocols, reduced equipment costs, and comput-erized interpretations have greatly enhanced the practicality and availability of this testing.Observations of heart rate are easily available data to compare performance on an EST withdemands of job activities. At sub-maximal workloads, the relationship between heart rate and oxy-gen uptake (workload) is almost linear.(3)

Maximal testing with the aim of establishing safe levels of exercise or work performance can beperformed on any person and aerobic capacity reported as METs (1 MET = metabolic equivalent =energy expended at rest = 3.5 mL 02 /Kg/min).(3)

It is prudent to selectively perform supervised EST in respirator users who are expected to engagein heavy work if the evaluating PLHCP suspects deconditioning or coronary disease on the basisof signs, symptoms, or risk factors. EST for cardiovascular fitness may be necessary, especially ifthe work requires strenuous exertion, heat stress will be present, or a clinical indication of a cardio-vascular abnormality is present. The use of respirators in conjunction with water-impermeable pro-tective clothing can impose significant thermal stress. Such situations occur in the hazardouswaste, nuclear, and other industries. EST may also be advisable in the first two situations for work-ers older than 45 years of age regardless of clinical status. Resting ECGs are not predictive of riskfrom respirator use during exertion.(4)

EST requires the active cooperation and informed consent of the participant. Stress testing maynot detect significant coronary disease, especially in asymptomatic workers.(5) Although this test-ing cannot reliably identify all persons at risk of an acute event it may increase the margin of safe-ty. Workers should be evaluated on an individual basis and additional testing such as imaging stud-ies may be recommended for those considered to be at higher risk.(3)

Supervision during EST should be provided by a physician with appropriate training and experi-ence.(6)

Many protocols and types of equipment (treadmill, cycle ergo meter) are available to perform EST.The choice of equipment and protocol should be the decision of the testing physician.

Workers are less likely to have clinically significant CAD if they achieve a level of 10 METs func-tional capacity(7) with absence of arrhythmia, abnormal blood pressure response, or ischemia andare usually capable of performing heavy physical work and work in high heat stress situations.(8)


10


References1) Evaluations of Impairment/Disability Secondary to Respiratory Disorders, Official

Statement – American Thoracic Society, Adopted March, 19862) ATS/ACCP Statement on Cardiopulmonary Exercise Testing, Adopted by the American

Thoracic Society (ATS) on March 1, 2002 and the American College of ChestPhysicians (ACCP) on November, 1, 2002

3) Temte, J.V.: Cardiovascular Conditions and Worker Fitness and Risk. Occ. Med. Stateof the Art Reviews 3(2):241–254 (1988).

4) American Thoracic Society: Respiratory Protection Guidelines, Am. J. Respir. Crit.Care Med. 154:1153–1165 (1996).

5) Gibbons, R.J., G.J. Balady, J.W. Beasley, J.T. Bricker, W.F. Duvernoy, FroelicherV.F., et al: ACC/AHA guidelines for exercise testing. A report of the American Collegeof Cardiology/American Heart Association Task Force on Practice Guidelines(Committee on Exercise Testing). J. Am. Coll. Cardiol. 30:260–311 (1997).

6) Rodgers, G.P., J.Z. Ayurum, et al.: American College of Cardiology/American HeartAssociation Clinical Competence Statement on Stress Testing: A Report of theAmerican College of Cardiology/American Heart Association/American College ofPhysicians, American Society of Internal Medicine Task Force on Clinical CompetenceCirculation J02:1726–1738 (2000).

7) Whaley, M.H., (ed.): ACSM’s Guidelines for Exercise Testing and Prescriptions,American College of Sports Medicine, 7th edition, Baltimore, Lippincott – Williams &Wilkins 2006

8) Criteria for a Recommended Standard Occupational Exposure to Hot EnvironmentsRevised Criteria, 1986 DHHS (NIOSH) Publication No. 86-113, 1986.


11


12


13


14


15


16


17


Annex C: Spirometry

Introduction

Spirometry is the most frequently performed test of ventilatory function. However, since it is effort-dependent and requires attention to detail, failure to follow current American Thoracic Society(ATS) Guidelines often results in false positive test results.(1) The below-referenced ATS state-ments on equipment and test performance(2,3), interpretation of results(4), and screening for respira-tor use(5) are recommended as guidance. Since ATS Spirometry statements are periodically updat-ed, e.g., the 2005 ATS update(2,4) is In Press, users should consult the most recent versions of theATS Spirometry statements, available at http://www.thoracic.org. Similarly, the most current versionof the American College of Occupational and Environmental Medicine (ACOEM) Guidelines can befound at http://www.acoem.org.

Specific Criteria

Spirometry is not routinely required for medical clearance of respirator users. The respiratory sys-tem’s large reserve permits most healthy workers to tolerate the small respiratory impact of manyrespirators. However, moderate or severe reduction of ventilatory capacity may limit a subject’sability to use a respirator. “In the absence of other factors limiting the worker’s overall ability to tol-erate the demands of the job and the respiratory protective equipment, FEV1 (and FVC) of 60% orgreater of the predicted value suggest that a trial of respirator use is allowable. For light duty workusing low resistance respirators, even lower levels of function may not be disqualifying, but a morethorough clinical evaluation should be done.”(5) Because of their variability, forced expiratory flowrates (FEF25-75 and instantaneous flows) should not be used in the evaluation of medical fitness forrespirator use.

The (ATS) recommends spirometry testing for: 1) workers > 45-years-old who use SCBA withstrenuous exertion; 2) younger workers using SCBA with strenuous exertion who report respiratorysymptoms, or have abnormalities on the screening questionnaire; 3) all respirator users > age 55;and 4) workers reporting respiratory symptoms with the level of exertion required by their job.(5)

Unless recommended differently by the most current version of the ATS Spirometry Guidelines,spirometer performance should be documented by daily checks of the spirometer’s calibration.When testing a subject, the technician should describe and demonstrate the maneuver, enthusias-tically coach the subject, and try to record at least three “acceptable” curves (as defined by theATS) with up to 8 attempts if necessary, achieving repeatability (“reproducibility”) for both the FVCand the FEV1. The largest FVC and FEV1 are reported from the acceptable curves even if they arenot from the same maneuver, and FVC and FEV1 are corrected to body temperature (BTPS).Spirometry technicians should be highly motivated to conduct good tests and trained so that theycan judge the subject’s degree of effort and cooperation. ACOEM and the American ThoracicSociety recommend that technicians initially complete a NIOSH-approved (or similar) spirometrytraining course and periodically attend spirometry refresher courses.(1,2)

In the screening setting, spirometry test results are interpreted by comparing the observed FVCand FEV1, and their ratio, FEV1/FVC% with predicted average values and Lower Limits of Normal(LLN) derived from reference populations of non-smokers. The goal is to determine whether theworker’s results fall within the normal range, or below it, indicating possible respiratory impairment.Several prediction equations are referenced in the ACOEM Position Statement, and both ACOEMand ATS recommend use of the NHANES III prediction equation(1,4) if other prediction equationsare not required by applicable regulations. A flow chart for interpreting results following ATS recom-mendations is included in the ACOEM Statement.(1)


18


Finally, it is becoming routine for individuals over 45 years of age engaged in strenuous activities toundergo an Exercise Stress Test in addition to Spirometry.

1. American College of Occupational and Environmental Medicine: ACOEM PositionStatement: Spirometry in the Occupational Setting. J. Occup. Env. Med. 42:228–245(2000).

2. American Thoracic Society: European Respiratory Society: General Considerationsfor Lung Function Testing. Eur. Respir. J. 26(1):153–161 (2005).

3. American Thoracic Society: European Respiratory Society: Standardisation ofSpirometry, Eur. Respir. J. 26:319–338 (2005).

4. American Thoracic Society: European Respiratory Society: Interpretative Strategiesfor Lung Function Tests, Eur. Respir. J. 26(5):948–968 (2005).

5. American Thoracic Society: Respiratory Protection Guidelines. Am. J. Respir. Crit.Care Med. 154:1153–1165 (1996).


19


Annex D: Future Research Areas

Introduction

The final respiratory protection standard (29 CFR Parts 1910 and 1926 – Respiratory Protection)covers an estimated 5 million respirator wearers working in an estimated 1.3 million work places.There exists a wide variety of workers, work environments, physical stressors, and perceptions ofrisk. A recent well designed and executed retrospective analysis reported only 1.3 % of over 5000workers evaluated received limitations on respirator use.

Spirometry has become strongly associated with respirator use as many users are in respiratorysurveillance programs that involve periodic reevaluation to monitor the adverse effects of exposure.This secondary prevention/surveillance monitoring represents a major contribution of occupationalmedicine to society and has also resulted in the use of pulmonary function testing to determine jobsuitability. Careful studies of ventilation, resistance, hypoxia, tidal volume, expiratory time, inspiratorymuscle fatigue, and pleural pressures have resulted. More recently the cardiopulmonary relation-ship has emerged with recognition that angina and arrhythmias may be aggravated by hypoxia orhypercarbia.

Rationale

This standard considers functional capacity a cardiopulmonary issue. The presence or absence ofa “disease” may be almost incidental to work performance. An individual may be “disease free”, butunable to perform essential job functions or even climb a flight of stairs without interruption.

There is little “evidence based” science that applies directly to job suitability. There are, however,large bodies of literature that deal with Medical Screening, Pre Exercise Risk Stratification, CardiacRehabilitation, and Pulmonary Rehabilitation. The guidelines developed by these emerging disci-plines seem applicable to job-suitability evaluation given the caveat that the predictive value of anymedical testing has limits. We suggest that these disciplines can contribute much to the assess-ment of job suitability, and that this standard represents a humble beginning.

Any proposed process must also deal not only with science, but also with perceived risk to theworker, co-workers, and the public. Escalation of risk should not necessarily mean more medicaltests but may lead to increased scrutiny of the work force and a more conservative interpretation ofresults. This standard did consider the recommendations of certain consensus standards (DOT,FAA, NFPA) and attempted to use them to “benchmark” risk. “Evidence” is being slowly assembledby these agencies and guidelines are periodically modified. The consensus recommendations inthis standard must also be modified periodically as our ability to analyze and quantify risk evolves.

Research for Consideration:

Adoption of the OSHA questionnaire (or modifications of it) should be encouraged. An effective-ness survey program/process should then be developed that addresses the following:

• How are positive questionnaire responses dispositioned, and by who?• How are employees with (common) established diseases (e.g., post myocardial infarction)

evaluated?• Could a “functional capacity” standard be developed and included in job descriptions similar to

that developed for lifting as contained in the Dictionary of Occupational Titles?• Could a smaller questionnaire consisting of “critical items” be developed?


American Industrial Hygiene Association2700 Prosperity Ave., Suite 250

Fairfax, VA 22031(703) 849-8888

[email protected]

Stock Number: SRPA06-716

®


Real-World Spirometry in the Workplace Townsend, M… · M.C. Townsend Associates, LLC •...

Documents

Transcript of Real-World Spirometry in the Workplace Townsend, M… · M.C. Townsend Associates, LLC •...