Respiratory Fit Testing Program

Policy & Procedures

2024

Re spira tory Fit Te stin g Pro gra m Policy & Proced ure s
O w n e r: R M I C li n ic a l G o v e r n a n c e 2 0 2 4 1
Table of Contents

Revisions ...............................................................................................................................................................3
1.0 Purpose ...................................................................................................................................................4
2.0 Scope .......................................................................................................................................................4
3.0 Roles and Responsibilities..................................................................................................................4
4.0 Equipment and Materials ...................................................................................................................5
5.0 Training and Development .................................................................................................................5
6.0 Fit Testing Procedures – General Requirements ...........................................................................6
7.0 Qualitative Fit Test (QLFT) Protocols ...............................................................................................9
8.0 Quantitative Fit Test (QNFT) Protocols .........................................................................................19
Program Contacts .............................................................................................................................................34

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 2
Revisions

Date Version D e s c ri p ti o n of C ha n ge

0 1 S e pt e m b e r 1 D o c u m e n t C re a tio n
2024

P o lic y & P r o c e d u r e Ow ne r Verifie d Approve d by

Function S e ni o r M a n a g e r Cl i nic a l G o v e r n a nc e Vic e P re s i de nt Cli nic a l C o r p ora te M e dic a l Dire c t or

O p e ra ti o ns
Na me M a tt he w R. B o n n e tt E ric F a r m e r R ic h a r d M i s ia s ze k , M D
Date 01 October 2024 03 October 2024 05 October 2024
Si gnat ure // S// // S//

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 3
1.0 Purpose
Re mo te Medical In c.® (RMI) e nd ea vors to m ain tain a safe and he alth y wo rkin g
en viro n men t for its sta ff and p a tie nts. In supp ort of this goal, RMI is co mmitted to
de velopin g and imple me n tin g Re spira tor Fit Te stin g Po licy a nd Pro ce du re s for the
ben e fit of its e mplo ye es, co ntra ctors, and p a tien ts. All RMI e mp lo ye e s/co n tra cto rs a re
re qu ire d to re vie w th is d o cu me n t d u rin g o n b o ard in g a n d /o r a s a ssign e d /re qu ire d in
a cco rd a n ce with co rp ora te p olicy.

Th is p ro to col o u tlin e s p ro ce d ure s fo r co n d u ctin g b o th qu a lita tive a n d qu a n tita tive

re spira tor fit te stin g, e n su rin g a se cu re a n d p ro p e r fit to sa fe gu a rd wo rke rs fro m
airb orn e h a za rd s. It is d e sign e d to co mp ly with sta n d a rd s su ch a s O SH A 2 9 C FR
1 9 1 0 .1 3 4 a n d simila r re gu la tio n s.

Fin ally, th is d o cu me n t is to se rve a s a re fe re n ce to e sta b lish p ro ce d ure s fo r:

- Qu a lita tive Fit Te stin g (QL F T) – a p a ss/fa il te st u sin g th e su b je ct’s se n se s (ta ste ,
sme ll) to d e te rmin e re sp ira tor fit. RMI ro u tin e ly co n d u cts th is te st.

- Qu a n tita tive Fit Te stin g ( QN FT) – a me a s u re me n t-b a se d te st u sin g in stru me n ta tio n

to e va lua te fit. RM I d o e s n o t ro u tin e ly co n d u ct th is te st.

2.0 Scope
Th is p olicy a p p lie s to a ll me d ical p ro fe ssio n als re qu ire d to co n d u ct re spira to r fit
te stin g in th e e xe cu tio n o f th eir d aily d u tie s , in clu d in g b u t n o t limited to p h ysicia n s,
n urse p ra ctitio n e rs, p h ysicia n a ssista n ts, a n d p ara me d ics. Th e p o licy a lso co ve rs a ll
re mo te h e alth ca re fa cilitie s a n d te a ms a n d is a p plica ble to wo rk e n vo rin me n ts th a t
a re re qu ire d to we a r tigh t-fittin g re sp ira tors fo r pro te ctio n fro m h a za rd o u s
su b sta n ce s in th e wo rkp la ce .

3.0 Roles and Responsibilities

Client: En su re s e mp lo ye e s u n d e rgo fit te st in g p rio r to in itial u se , a n n u ally, a n d
wh e n e ve r th ere is a ch a n ge th a t ma y a ffe ct th e fit.

Employee or Contractor: Mu st co mp ly with fit te stin g in a cco rd a n ce with clie n t

p olicy a n d re po rt ch a n ge s in fa cia l stru ctu re or co n d ition th a t ma y a ffe ct th e fit.

Qualified Fit Tester: Re sp o n sible fo r co n d u ctin g fit te stin g fo llo win g th is p ro to co l.

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 4
4.0 Equipment and Materials
For Qualitative Fit Testing (QLFT):
- Te st so lu tio n s (e .g., Bitre x™ , sa cch a rin )
- Fit te st h o o d s
- Ne b u lize r(s)
- Re sp ira tors (N9 5 , h a lf-ma sk, o r fu ll-fa ce p ie ce )

For Quantitative Fit Testing (QNFT):

- Po rta Co u n t ™ ma ch in e (o r simila r qu a n tita tive fit te stin g d e vice )
- Re sp ira to rs with a d a p ter fo r te st p o rts

5.0 Training and Development

O S HA d o e s n o t p ro vide a n o fficial ce rtifica t io n re qu ire me n t, b u t th e y d o re co mme n d
th a t th e follo win g sp e cific in itia l an d a n n u al re fre sh e r trainin g is p ro vid e d so th a t th e
clin ician co n d u ctin g fit te sts is co mp e te n t a n d co mp lia n t with O SH A's re sp ira to ry
p ro te ctio n sta n d a rd s.

Understanding OSHA Standards: Fa milia rity with O SH A' s re sp ira to ry p ro te ctio n

sta n d a rd (2 9 CFR 1 9 1 0 .1 3 4 ), in clud in g re q uire me n ts fo r re sp ira to r fit te stin g.

Fit Testing Protocols: Kn o wle d ge o f qu a lita tive (ta ste /sme ll) a n d qu a n tita tive
(le a ka ge ) fit te stin g me th o d s.

Respirator Types: Un d ersta n d in g d iffe ren t typ e s o f re sp ira to rs a n d th e ir

a p pro p ria te u se (e .g., N9 5 , h a lf-ma sk , fu ll-fa ce re spira tors).

Fit Test Procedures: Ab ility to p ro p e rly p e rfo rm a fit te st, in clu d in g p re p a rin g th e
p erso n fo r te stin g, se le ctin g th e righ t re sp ira tor, a n d fo llo win g th e fit te stin g p ro to co l.

Training on Equipment Use: Ha nd s-o n train in g o n u sin g fit te st e qu ip me n t a n d

in te rp re tin g re su lts, p a rticula rly fo r qu a n tit a tive fit te stin g.

Recordkeeping and Compliance: Fa milia rity with O SH A' s re qu ire me n ts fo r

d o cu me n tin g fit te sts a n d ma in tain in g re co rd s.

Links to training sites and source references for above information:

https://www.osha.gov/respiratory-protection/training: On lin e train in g so u rce fo r

re spira tor fit te stin g

NIOSH or Manufacturer-Sponsored Training: So me re sp ira tor ma n u fa ctu re rs o ffe r

train in g o n th e ir e qu ip me n t a n d fit te stin g me th o d s.

Qualitative and Quantitative Testing Comparison Video

3M Qualitative Fit Testing Overview Video

Qualitative Respirator Fit Testing Training Video

3M Respiratory Protection Training Video Series

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 5
6.0 Fit Testing Procedures – General Requirements
o Th e e mp lo ye r sh all co n d u ct fit te stin g u sin g th e fo llo win g p ro ce d u re s. Th e
re qu ire me n ts in th is a p p e n dix a p p ly to a ll O S HA-a c ce p te d fit te st me th o d s, b o th
QL F T a n d QNF T.

o Th e te st su b je ct sh a ll b e allo we d to p ick th e mo st a cce p ta b le re sp ira to r fro m a

su fficien t n u mb e r o f re sp ira to r mo d e ls a n d size s so th a t th e re sp ira to r is
a cce p ta b le to , a n d co rre ctly fits, th e u se r.

o Prio r to th e sele ctio n p ro ce ss, th e te st su b je ct sh a ll b e sh o wn h o w to p u t o n a

re spira tor, h o w it sh o u ld b e p o sitio n e d on t h e fa ce , h o w to se t stra p te n sio n
a n d ho w to d e te rmin e a n a cce p ta b le fit. A mirro r sh a ll b e a va ila ble to a ssist th e
su b je ct in e va lu a tin g th e fit a n d p o sitio nin g o f th e re spira tor. Th is in stru ctio n
ma y n o t co n stitu te th e su b je ct's fo rma l tra inin g o n re sp ira tor u se , b e ca u se it is
o nly a re vie w.

o Th e te st su b je ct sh a ll b e in fo rme d th a t h e /sh e is b e in g a ske d to se le ct th e

re spira tor th a t p ro vide s th e mo s t a cce p ta b le fit. Ea ch re sp ira tor re pre se n ts a
diffe re n t size a n d sh a p e , a nd if fitte d a n d u se d p rop e rly, will p ro vid e a d e qu a te
p ro te ctio n .

o Th e te st su b je ct sh a ll b e in stru cte d to h o ld e a ch ch o se n fa ce p ie ce u p to th e
fa ce a n d elimin a te th o se th a t o b vio u sly d o n o t give a n a cce p ta b le fit.

o Th e mo re a cce p ta b le fa ce pie ce s a re n o te d in ca se th e o n e se le cte d p ro ve s

u n a cce p ta ble ; th e mo st co mfo rta b le ma sk i s d o n n e d an d wo rn a t le a st five
min u te s to a sse ss co mfo rt. Assista n ce in a sse ssin g co mfo rt ca n b e give n b y
discu ssin g th e p o in ts in th e follo win g ite m A.6 . If th e te st su b je ct is n o t fa miliar
with u sin g a p a rticula r re sp ira tor, th e te st s u bje ct sh a ll b e dire cte d to d o n the
ma sk se ve ra l time s a n d to a d ju st th e stra p s e a ch time to b e co me a d e p t a t
se ttin g p ro p er te n sio n o n th e stra p s.

o As se ss me n t o f co mfo rt sh a ll in clu d e a re vie w o f th e fo llo win g p o in ts with th e

te st su b je ct a n d allo win g th e te st su b je ct a d e qu a te time to d e te rmin e th e
co mfo rt o f th e re sp ira to r:

• Po sitio n o f th e ma sk o n th e n o se

• Ro o m fo r e ye p ro te ctio n

• Ro o m to ta lk

• Po sitio n o f ma sk o n fa ce a n d ch e e k s

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 6
 o Th e fo llo win g crite ria sh all b e u se d to he lp d e termin e th e a d e qu a cy o f th e
re spira tor fit:

• Ch in pro p e rly p la ce d ;

• Ad e qu a te stra p te n sio n , n o t o verly tigh te n e d ;

• Fit a cro ss n o se b rid ge ;

• Re sp ira tor o f p ro pe r size to sp a n d ista n ce fro m n o se to ch in ;

• Te n d e n cy o f re sp ira to r to slip ;

• Se lf-o b se rva tio n in mirro r to e valu a te fit a n d re sp ira tor p o sitio n .

o Th e te st su b je ct sh a ll co n d u ct a u se r se al ch e ck, e ith e r th e ne ga tive a n d

p o sitive p re ssu re se a l ch e cks d e scrib e d in a p p en d ix B-1 o f th is se ctio n o r
th o se re co mme n d e d b y th e re sp ira to r ma n u fa ctu rer wh ich p ro vide e qu iva le n t
p ro te ctio n to th e p ro ce d u re s in a pp e n d ix B- 1 . Be fo re co n d u ctin g th e n e ga tive
a n d po sitive p re ssu re ch e cks, th e su b je ct s h all b e told to se a t th e ma sk o n th e
fa ce b y mo vin g th e h e a d fro m sid e -to-sid e a n d up a n d d o wn slo wly wh ile ta kin g
in a fe w slo w d e e p b re a th s. An o th e r fa ce pie ce sh a ll b e se le cte d a n d re te ste d if
th e te st su b je ct fa ils th e u se r se a l ch e ck te sts.

o Th e te st sh a ll n o t b e co n du cte d if th e re is a n y h air gro wth b e twe e n th e s kin a n d

th e fa ce pie ce se a lin g su rfa ce , su ch a s stu b ble b e a rd gro wth , b e a rd , mu sta ch e
o r sid e b u rn s wh ich cro ss th e re sp ira to r se a lin g su rfa ce . An y t yp e o f a p p a rel
wh ich in terfe re s with a sa tisfa cto ry fit sh a ll b e alte re d or re mo ve d .

o If a te st su b je ct e xh ib its difficu lty in bre a th in g d u rin g th e te sts, sh e o r h e sh all

b e re fe rre d to a p h ysicia n or o th e r lice n se d h e alth ca re p ro fe ssio n a l, a s
a p pro p ria te , to d e te rmine wh e th e r th e te st su b je ct ca n we a r a re spira tor wh ile
p erfo rmin g h e r o r his d u tie s.

o If th e e mp lo ye e find s th e fit o f th e re sp ira to r un a cce p ta b le , th e te st su b je ct

sh a ll b e give n th e o p p o rtu nity to se le ct a d iffe ren t re sp ira to r a n d to b e re te ste d .

o Exe rcise re gime n . Prio r to th e co mme n ce m e n t o f th e fit te st, th e te st su b je ct

sh a ll b e give n a d e scrip tio n o f th e fit te st a n d th e te st su b je ct's re sp o n sibilitie s
d urin g th e te st p ro ce d u re . Th e d e scrip tio n o f th e pro ce ss sh a ll in clud e a
d e scrip tio n o f th e te st e xe rcise s th a t th e su bje ct will b e p erfo rmin g. Th e
re spira tor to b e te ste d sh a ll be wo rn fo r a t le a st 5 min u te s b e fo re th e sta rt o f
th e fit te st.

o Th e fit te st sh a ll be p e rforme d wh ile th e te st su b je ct is we a rin g a n y a p p lica b le

sa fe ty e qu ip me n t th a t ma y b e wo rn d u rin g a ctu a l re sp ira to r u se wh ich co u ld
in te rfe re with re sp ira to r fit.

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 7
 o Te st Exe rcise s.

• E mp lo ye rs mu st p e rfo rm th e fo llo win g te st e xe rcise s fo r all fit te stin g

me th o d s p re scribe d in this a p p e n d ix, e xce p t fo r th e two mo d ifie d a mb ie n t
a ero so l CN C qu a n tita tive fit te stin g p ro to co ls, th e CN P qu a n tita tive fit
te stin g p ro to co l, a n d th e CN P R E D ON qu a n tita tive fit te stin g p ro to co l.
Fo r th e mo d ifie d a mb ie n t a ero so l CN C qu a n tita tive fit te stin g p ro to co ls,
e mp lo ye rs sh a ll e n su re th a t th e te st su b je cts (i.e ., e mp lo ye e s) pe rfo rm
th e e xe rcise p ro ce d u re sp e cifie d in Pa rt I. C.4 (b ) o f this a p p e n dix fo r fu ll-
fa ce p ie ce a n d h a lf-ma sk e la sto me ric re spira tors, o r th e e xe rcise
p ro ce d u re sp e cifie d in Pa rt I.C.5 (b ) fo r filte rin g fa ce p ie ce re sp ira to rs.
E mp lo ye rs sh a ll e n su re th a t th e te st su b je cts (i.e ., e mp lo ye e s) pe rfo rm
th e e xe rcise p ro ce d u re sp e cifie d in Pa rt I. C.6 (b ) o f this a p p e n dix fo r th e
CN P qu a n tita tive fit te stin g p ro to co l, or th e e xe rcise pro ce d u re d e scrib e d
in Pa rt I. C.7 (b ) o f th is a p pe n d ix fo r th e CN P R ED O N qu a n tita tive fit
te stin g p ro to co l. Fo r th e re ma in in g fit te stin g me th o d s, e mp lo ye rs sh a ll
e n su re th a t th e te st e xe rcise s a re p e rforme d in th e a p p rop ria te te st
e n viro n me n t in th e follo win g ma n n e r:

 No rma l b re a th in g. In a n o rma l sta n d in g p o s itio n , with o u t ta lkin g,

th e su b je ct sh a ll b re a th e n o rma lly.

 De e p b rea th in g. In a n o rma l sta n d in g p o sitio n , th e su bje ct sh a ll

b re a th e slo wly a n d d e e ply, ta kin g ca u tio n t o n o t h yp erve n tila te .

 Tu rnin g h e a d sid e to sid e . Sta n d in g in p la ce , th e su b je ct sh a ll

slo wly tu rn his/h e r h e ad fro m sid e to sid e b e twe e n th e e xtre me
p o sitio n s o n e a ch sid e . Th e h e a d sh all b e h eld a t e a ch e xtre me
mo me n ta rily so th e su b je ct ca n in h a le a t e a ch sid e .

 Mo vin g h e a d u p a n d d o wn . Sta n d in g in p la ce , th e su b je ct sh a ll
slo wly mo ve h is/h e r h e a d up a n d d o wn . Th e su b je ct sh a ll b e
in stru cte d to in h ale in th e up p o sitio n , lo o kin g to wa rd th e ce ilin g.

 Ta lkin g. Th e su b je ct sh a ll talk o u t lo u d slo wly a n d lou d e n o u gh

so a s to b e h e a rd cle a rly b y th e te st co n d u cto r. Th e su b je ct ca n
rea d fro m a p re p are d te xt su ch a s th e Ra in b o w Pa s sa ge , co u n t
b a ckwa rd fro m 1 0 0 , o r re cite a me mo rize d p o e m o r so n g.

 Grima ce . Th e te s t su b je ct sh a ll grima ce b y smilin g o r fro wn in g.

(This a p p lie s o n ly to QNF T te stin g; it is n o t p erfo rme d fo r QL F T)

 Be n d in g o ve r. Th e te st su b je ct sh a ll be n d a t th e wa ist a s if
h e /sh e we re to to u ch h is/h er to e s. Jo g gin g in p la ce sh a ll b e
su b stitu te d for th is e xe rcise in th o se te st e n viro n me n ts su ch a s
sh ro ud typ e QN FT o r QL FT u n its th a t d o n o t p ermit b e n d in g o ve r
a t th e wa ist.

 No rma l b re a th in g. In a n o rma l sta n d in g p o sitio n , with o u t ta lkin g,

th e su b je ct sh a ll b re a th e n o rma lly.

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 8
 o Ea ch te st e xe rcise sh a ll b e p e rforme d fo r o n e min u te e xce p t fo r th e grima ce
e xe rcise wh ich sh a ll b e p erfo rme d fo r 1 5 se co n d s. Th e te st su b je ct sh a ll b e
qu e stio n e d b y th e te st co n d u cto r re ga rd in g th e co mfo rt o f th e re sp ira to r u p on
co mp le tion o f th e p ro to co l. If it ha s b e co me u n a cce p ta ble , a n o th e r mo d el o f
re spira tor sh a ll b e tried . Th e re sp ira tor sh a ll n o t b e a dju ste d o n ce th e fit te st
e xe rcise s b e gin . An y a d ju stme n t vo id s th e te st, a n d th e fit te st mu st b e
rep e a te d .

Rainbow Passage. W h e n the su n ligh t strike s rain d ro p s in th e a ir, th e y a ct like a p rism

a n d form a ra in b o w. Th e ra in b o w is a d ivisio n o f wh ite ligh t in to ma n y co lo rs. Th e se
ta ke th e sh a p e o f a lo n g ro u n d a rch , with its p a th h igh a b o ve , a n d its two e n d s
a p p are n tly b e yo n d th e h o rizo n .

7.0 Qualitative Fit Test (QLFT) Protocols

GENERAL

Th e e mp lo ye r sh all e n su re tha t p e rso n s a d min isterin g QL FT a re a ble to p re pa re te st

so lu tio n s, ca libra te e qu ip me n t a n d p e rform te sts p ro p e rly, re co gn ize in va lid te sts,
a n d en su re th a t te st e qu ip me n t is in p ro p er wo rkin g o rd e r.

Th e e mp lo ye r sh all e n su re tha t QL FT e qu ip me n t is ke p t cle a n a n d we ll ma in ta in e d so

a s to o p e ra te with in th e p ara me te rs fo r wh ich it wa s d e sign e d .

1. ISOAMYL ACETATE PROTOCOL

No te : Th is p ro to co l is n o t a p p ro pria te to u se fo r th e fit te stin g o f p a rticu la te

re spira tors. If u se d to fit te st p a rticu la te re sp ira to rs, th e re spira to r mu st b e e qu ip p e d
with a n orga n ic va p o r filter.

o Od o r Th re sh o ld Scre e n in g. Od o r th re sh old scre e nin g, p e rfo rme d with o u t

we a rin g a re sp ira to r, is in te n d e d to de te rmin e if th e in divid u al te ste d ca n
d e te ct th e o d or o f iso a myl a ce ta te a t lo w le ve ls.

• Th re e 1-lite r gla ss ja rs with me ta l lid s a re re qu ire d .

• Od o r-fre e wa te r (e .g., d istille d or sp rin g wa te r) a t a p p ro xima te ly

2 5 ° C (7 7 ° F) sh a ll b e u se d fo r th e so lu tio n s.

• Th e iso a myl a ce ta te (IA A) (a lso kn o wn a t iso p e n tyl a ce ta te)

sto ck so lu tio n is pre p a red b y a d d in g 1 ml o f p u re I A A to 8 0 0 ml
o f o d or-free wa te r in a 1 -liter jar, clo sin g th e lid a n d sh a kin g fo r
3 0 se co n d s. A n e w so lu tio n sh all b e pre p a re d a t le a st we e kly.

• Th e scre e n in g te st sh a ll b e co n d u cte d in a roo m se p a ra te fro m

th e ro o m u se d fo r a ctu a l fit te stin g. Th e t w o ro o ms sh a ll b e we ll-
ve n tila te d to p re ve n t th e o d o r o f IA A fro m b e co min g e vid e n t in
th e ge n e ral ro o m a ir wh e re te stin g ta ke s p la ce .

• Th e o d or te st so lu tio n is pre p a red in a se c o n d ja r b y p la cin g 0 .4

ml o f th e sto ck so lu tio n in to 50 0 ml o f o d o r-fre e wa te r u sin g a

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 9
 cle an d ro p p er o r pip e tte . Th e so lu tion sh a ll b e sh a ke n fo r 3 0
se co n d s a n d a llo we d to sta n d fo r two to th re e min u te s so th a t
th e IA A co n ce n tra tio n a b o ve th e liqu id ma y rea ch e qu ilibriu m.
Th is so lu tio n sh a ll b e u se d fo r o nly o n e d a y.

• A te st b la n k sh a ll b e p re p a re d in a th ird jar b y a d d in g 5 0 0 c c o f
o d or-fre e wa te r.

• Th e o d or te st a n d te st b la n k ja r lid s sh a ll b e la b e led (e .g., 1 a n d

2 ) for jar id e n tifica tion . L a b e ls sh a ll b e pla ce d o n th e lid s so th a t
th e y ca n b e p e ele d o ff p e rio d ically a n d switch e d to ma in tain th e
in te grity o f th e te st.

• Th e fo llo win g in stru ctio n sh a ll b e typ e d o n a ca rd an d p la ce d o n

th e ta ble in fro n t o f th e two te st ja rs (i.e ., 1 a n d 2): “Th e p u rpo se
o f th is te st is to d e te rmin e if yo u ca n s me ll b a n an a o il a t a lo w
co n ce n tra tio n . Th e two b o ttle s in fro n t o f yo u co n tain wa te r. On e
o f th e se b o ttle s a lso co n ta in s a sma ll a mo u n t o f b a n an a o il. Be
su re th e co ve rs a re o n tigh t, th e n sh a ke e a ch b o ttle for two
se co n d s. Un s cre w th e lid o f e a ch b o ttle , o n e a t a time , a n d sn iff
a t th e mo u th o f th e b o ttle . In dica te to th e t e st co n d u cto r wh ich
b o ttle co n ta in s b a n a n a o il.”

• Th e mixtu re s u se d in th e IA A o d o r d e te ctio n te st sh a ll b e
p re p a re d in a n are a se p a ra te fro m wh e re th e te st is p e rforme d ,
in o rd er to p re ve n t o lfa ctory fa tigu e in th e su b je ct.

• If th e te st su b je ct is u n a b le to co rre ctly ide n tify th e ja r

co n ta in in g th e o d o r te st so lu tion , th e I A A q u alita tive fit te st sh a ll
n o t b e p erfo rme d .

• If th e te st su b je ct co rre ctly ide n tifie s th e ja r co n tain in g th e o d o r

te st so lu tion , th e te st su b je ct ma y p ro ce e d to re spira tor
se le ctio n a n d fit te stin g.

o Iso a myl Ace ta te Fit Te s t

• Th e fit te st ch a mb e r sh a ll b e a cle a r 5 5-ga l lo n d ru m lin e r

su sp e n d e d in ve rte d o ve r a 2-fo o t d ia me te r fra me so th a t th e to p
o f th e ch a mb e r is a b o u t 6 in ch e s a b o ve th e te st su b je ct's h e a d . If
n o dru m lin er is a va ila b le , a simila r ch a mb e r sh all b e co n stru cte d
u sin g p la stic sh e e tin g. Th e in sid e to p ce n te r o f th e ch a mb e r sh a ll
h a ve a sma ll h o o k a tta ch e d .

• Ea ch re sp ira tor u se d fo r th e fittin g a n d fit t e stin g sh a ll b e

e qu ip p e d with orga n ic va p o r ca rtrid ge s o r o ffe r pro te ctio n a ga in st
o rga n ic va p o rs.

• Afte r se le ctin g, d o n n in g, a n d p ro p e rly a d ju stin g a re sp ira to r, th e

te st su b je ct sh a ll we a r it to th e fit te stin g ro o m. Th is ro o m sh a ll
b e se p ara te fro m th e ro o m u se d fo r o d o r th re sh old scre e nin g a n d
Re spira tory Fit Te stin g Po licy & Pro ce dure s
O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 10
 re spira tor se le ctio n , a nd sh a ll b e we ll-ve n tila te d , a s b y a n
e xh a u st fa n o r la b h o o d , to pre ve n t ge n e ra l roo m co n ta min a tion .

• A co p y o f th e te st e xe rcise s a n d a n y p re p a red te xt fro m wh ich th e

su b je ct is to re a d sh a ll b e ta p e d to th e in sid e o f th e te st ch a mb e r.

• Up o n e n te rin g th e te st ch a mb e r, th e te st s u bje ct sh a ll b e give n a

6 -in ch b y 5 -in ch p ie ce o f p a p er to we l, o r o th er p o ro u s, a b so rbe n t,
sin gle -ply ma te rial, fo ld e d in h a lf a nd we tte d with 0 .7 5 ml o f p u re
IA A. Th e te st su b je ct sh a ll h a n g th e we t to we l o n th e h oo k a t th e
to p o f th e ch a mb e r. An I A A te st swa b o r a mp u le ma y b e
su b stitu te d for th e I AA we tte d p a p e r to we l p ro vid e d it h a s b e e n
d e mo n stra te d th a t th e alte rn a tive I A A so u rce will ge n e ra te a n IA A
te st a tmo sp h e re with a co n ce n tra tion e qu iv ale n t to th a t ge n e ra te d
b y th e p a p er to we l me th o d .

• Allo w two min u te s fo r th e IA A te st co n ce n tra tio n to sta b ilize

b e fore sta rtin g th e fit te st e xe rcise s. Th is wo u ld b e a n a p p rop ria te
time to ta lk with th e te st su b je ct; to e xp la in th e fit te st, th e
imp o rta n ce o f h is/h e r co o p era tio n , a nd th e p urp o se fo r th e te st
e xe rcise s; o r to d e mo n stra te so me o f th e e xe rcise s.

• If a t a n y time d u rin g th e te st, th e su b je ct d e te cts th e b a n a n a-like

o d or o f IA A, th e te st is fa ile d . Th e su b je ct sh a ll qu ickly e xit fro m
th e te st ch a mb e r a n d lea ve th e te st a re a to a vo id olfa cto ry
fa tigu e .

• If th e te st is fa ile d , th e su b je ct sh a ll re tu rn to th e se le ctio n ro o m
a n d re mo ve th e re sp ira tor. Th e te st su b je ct sh a ll re p ea t th e o d o r
se n sitivity te st, se le ct a n d p u t o n a no th e r re sp ira to r, re tu rn to th e
te st a re a a nd a ga in b e gin th e fit te st p ro ce d ure d e scrib ed in (b)
(1) th ro u gh (7 ) a b o ve . Th e p ro ce ss co n tin u e s u n til a re spira to r
th a t fits we ll ha s b e e n fo u n d . Sh o u ld th e o d or se n sitivity te st b e
fa ile d , th e su bje ct sh a ll wa it a t lea st 5 min u te s b e fo re re te stin g.
Od o r se n sitivity will u su a lly h a ve re tu rn e d b y th is time .

• If th e su b je ct p a sse s th e te st, th e e fficie n c y o f th e te st p ro ce d u re

sh a ll b e d e mo n stra te d b y h a vin g th e su b je ct b rea k th e re sp ira to r
fa ce se a l a n d ta ke a bre a th b e fore e xitin g t h e ch a mb e r.

• W h e n th e te st su b je ct le a ve s th e ch a mb e r, th e su b je ct sh a ll
re mo ve th e sa tu ra te d to we l an d re turn it to th e p erso n co n d u ctin g
th e te st, so th a t th e re is n o sign ifica n t IA A co n ce n tra tio n b uild u p
in th e ch a mb e r d u rin g su b se qu e n t te s ts. Th e u se d to we ls sh a ll b e
ke p t in a self-se a lin g p la stic b a g to ke e p th e te st a re a fro m b e in g
co n ta min a te d .

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 11
 2. SACCHARIN SOLUTION AEROSOL PROTOCOL

Th e e n tire scre e n in g a n d te stin g p ro ce d u re sh a ll b e e xp lain e d to th e te st

su b je ct p rior to th e co n d u ct o f th e scre e n in g te st. No te : If th e te st su b je ct e a ts
o r d rin ks so me th in g s we e t b e fo re th e scre e nin g te st, h e /sh e ma y b e u n a ble to
ta ste th e we a k sa c ch a rin so lu tion .

o Ta ste th re sh o ld scre en in g. Th e sa cch a rin ta ste th re sh old scre e n in g,

p erfo rme d with o u t we a rin g a re sp ira to r, is in te n de d to d e te rmin e wh e th e r
th e in d ivid u a l b ein g te ste d ca n d e te ct th e t a ste o f sa cch a rin .

• Du rin g th re sh o ld scre e n in g a s we ll a s d u rin g fit te stin g, su b je cts sh a ll

we a r a n e n clo su re a b o u t th e he a d a n d sh o uld e rs th a t is a p pro xima te ly 1 2
in ch e s in d ia me te r b y 1 4 in ch e s ta ll with a t le a st th e fro n t p o rtio n cle ar
a n d th a t allo ws fre e mo ve me n ts o f th e h e a d wh e n a re spira tor is wo rn . An
e n clo su re su b sta n tially similar to th e 3 M h o o d a sse mb ly, p a rts # FT 1 4
a n d # FT 1 5 co mb in e d , is a d e qu a te .

• Th e te st e n clo su re sh all h a ve a 3 ⁄4 -in ch (1 .9 cm) h o le in fro n t o f th e te st

su b je ct's n o se a n d mo u th a re a to a cco mmo d a te th e ne b u lize r n o zzle .

• Th e te st su b je ct sh a ll d on th e te st e n clo su re . Th ro u gh o u t th e th re sh old
scre e nin g te s t, th e te st su b je ct sh a ll b re a th e th ro u gh h is/h e r sligh tly o p e n
mo u th with to n gu e e xte n d e d . Th e su b je ct i s in stru cte d to re p o rt wh e n
h e /sh e d e te cts a swe e t ta ste .

• Usin g a De Vilb iss Mo d e l 4 0 In h a la tio n Me d ica tio n Ne b u lize r o r e qu iva le n t,

th e te st co n d u cto r sh a ll sp ra y th e th re sh old ch e ck so lu tio n in to th e
e n clo su re . Th e n o zzle is d ire cte d a wa y fro m th e n o se a n d mo u th o f th e
p erso n . Th is n e b u lize r sh a ll b e cle a rly ma r ke d to d istin gu ish it fro m th e fit
te st so lu tion n e b u lize r.

• Th e th re sh old ch e ck so lu tio n is pre p a red b y d isso lvin g 0 .8 3 gra m o f

so d iu m sa cch a rin US P in 1 0 0 ml o f wa rm w a ter. It ca n b e p re p a red b y
p u ttin g 1 ml o f th e fit te st so lu tio n (se e (b )(5 ) b e lo w) in 1 0 0 ml o f d istille d
wa te r.

• To p ro du ce th e a e ro so l, th e ne b u lize r b u lb is firmly s qu e e ze d so th a t it
co lla p se s co mp le te ly, th e n rele a se d a n d allo we d to fu lly e xp a n d .

• Te n squ e e ze s a re rep e a te d rap idly a n d th e n th e te st su b je ct is a ske d

wh e th e r th e sa cch a rin ca n b e ta ste d . If th e te st su b je ct re p orts ta stin g th e
swe e t ta ste d u rin g th e te n s qu e e ze s, th e s cre e nin g te st is co mp le te d . Th e
ta ste th re sh old is n o te d a s te n re ga rdle ss o f th e n u mb e r o f squ e e ze s
a ctu a lly co mp le te d .

• If th e first re sp o n se is n e ga tive , te n mo re s qu e e ze s a re re p e a te d ra p id ly
a n d th e te st su b je ct is a ga in a ske d wh e th e r th e sa cch a rin is ta ste d . If th e
te st su b je ct re p orts ta stin g th e swe e t ta ste d urin g th e se co n d te n
squ e e ze s, th e scre e n in g te st is co mp le te d . Th e ta ste th re sh o ld is n o te d
a s twe n ty re ga rd le ss o f th e n u mb e r o f s qu e e ze s a ctu a lly co mp le te d .
Re spira tory Fit Te stin g Po licy & Pro ce dure s
O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 12
 • If th e se co n d re sp o n se is n e ga tive , te n mo re squ e e ze s a re re p e a te d
rap idly a n d th e te st su b je ct is a ga in a ske d wh e th e r th e sa cch a rin is
ta ste d . If th e te st su b je ct re p o rts ta stin g th e swe e t ta ste d u rin g th e th ird
se t o f te n squ e e ze s, th e scre e n in g te st is c o mp le te d . Th e ta ste th re sh old
is n o te d a s th irty re ga rd le ss o f th e n u mb e r o f squ e e ze s a ctu a lly
co mp le te d .

• Th e te st co n d u cto r will ta ke n o te o f th e nu mb e r o f squ e e ze s re qu ire d to

so licit a ta ste re sp o n se .

• If th e sa cch a rin is n o t ta ste d a fte r 3 0 s qu e e ze s (ste p 1 0 ), th e te st su b je ct

is u n ab le to ta ste sa cch a rin a n d ma y n o t p e rfo rm th e sa cch a rin fit te st.

• If a ta ste re sp o n se is e licite d , th e te st su b je ct sh a ll b e a ske d to ta ke n o te

o f th e ta ste fo r re fe re n ce in th e fit te st.

• Co rre ct u se o f th e n e b ulizer me a n s th a t a p p ro xima te ly 1 ml o f liqu id is

u se d a t a time in th e ne b u lize r b o d y.

• Th e n e b ulize r sh all b e th oro u gh ly rin se d in wa te r, sh a ke n d ry, a n d re fille d

a t le a st e a ch mo rn in g a n d a fte rn o o n o r a t le a st e ve ry fo u r h ou rs.

o Sa cch a rin so lu tio n a e ro sol fit te st p ro ce d u re .

• Th e te st su b je ct ma y n o t e a t, d rin k (e xce p t p la in wa te r), s mo ke , o r ch e w

gu m fo r 1 5 min u te s b e fo re th e te st.

• Th e fit te st u se s th e sa me e n clo su re d e scrib e d in 3 . (a) a b o ve .

• Th e te st su b je ct sh a ll d on th e e n clo su re while we a rin g th e re sp ira tor

se le cte d in se ctio n I. A . o f th is a p p e n dix. T h e re sp ira tor sh a ll b e p ro pe rly
a dju ste d a n d e qu ip p e d with a p articu la te filte r(s).

• A se co n d De Vilbiss Mo d e l 4 0 In h a la tio n Me dica tio n Ne b u lize r o r

e qu iva le n t is u se d to sp ra y th e fit te st so lu t io n in to th e e n clo su re . Th is
n e b ulizer sh a ll be cle a rly ma rke d to d istin g uish it fro m th e scre e n in g te st
so lu tio n n e b ulizer.

• Th e fit te st so lu tion is p re p are d b y a d din g 8 3 gra ms o f so d iu m sa cch a rin

to 1 0 0 ml o f wa rm wa te r.

• As b e fo re , th e te st su b je ct sh a ll b rea th e th ro u gh th e sligh tly o p e n mo u th

with to n gu e e xte n d e d , a n d re po rt if h e /sh e ta ste s th e swe e t ta ste o f
sa cch a rin .

• Th e n e b ulize r is in se rte d in to th e h ole in th e fron t o f th e e n clo su re a nd a n

in itia l co n ce n tra tio n o f sa cch a rin fit te st so lu tio n is sp ra ye d in to th e
e n clo su re u sin g th e sa me n u mb e r o f squ e e ze s (e ithe r 1 0 , 2 0 or 3 0
squ e e ze s) b a se d o n th e n u mb e r o f s qu e e z e s re qu ired to e licit a ta ste
re sp on se a s n o te d d u rin g th e scre e n in g te s t. A min imu m o f 1 0 s qu e e ze s
is re qu ire d .

Re spira tory Fit Te stin g Po licy & Pro ce dure s

O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 13
 • Afte r ge n e ra tin g th e a e ro so l, th e te st su b je ct sh a ll be in stru cte d to
p erfo rm th e e xe rcise s in se ctio n I. A. 1 4 . o f th is a p pe n d ix.

• Eve ry 3 0 se co n d s th e a e ro sol co n ce n tra tio n sh a ll b e rep le nish e d u sin g

o n e ha lf th e o rigin a l n u mb e r o f squ e e ze s u se d initially (e .g., 5 , 1 0 o r 1 5 ).

• Th e te st su b je ct sh a ll in d ica te to th e te st c o n d u ctor if a t a n y time d u rin g

th e fit te st th e ta ste o f sa cch a rin is d e te cte d . If th e te st su b je ct d o e s n o t
rep o rt ta stin g th e sa cch a rin , th e te st is p a s se d .

• If th e ta ste o f sa cch a rin is d e te cte d , th e fit is d e e me d u n sa tisfa cto ry a n d

th e te st is fa ile d . A d iffe re n t re sp ira to r sh all be tried a n d th e e n tire te st
p ro ce d u re is re p e a te d (ta ste th re sh o ld scre e nin g a n d fit te stin g).

• Sin ce th e n e b u lize r h a s a te n d e n cy to clo g d urin g u se , th e te st o p e ra to r

mu st ma ke p e rio d ic ch e cks o f th e n e b u lize r to e n su re tha t it is n o t
clo gge d . I f clo g gin g is fo u n d a t th e e n d o f th e te st se ssio n , th e te st is
in va lid .

3. BITREX ™ (D ENATONIUM BENZOATE) SOLUTION AEROSOL QUALITATIVE FIT

TEST PROTOCOL

Th e Bitre x ™ (De n a to n iu m b e n zo a te ) solu tio n a ero so l QL F T p ro to co l u se s th e

p u blish e d sa cch a rin te st p ro to co l b e ca u se th a t p ro to co l is wid ely a cce p te d .
Bitre x is ro u tin e ly u se d a s a ta ste a ve rsio n a ge n t in h o u se h old liqu id s wh ich
ch ild re n sh o uld n o t b e drin kin g a n d is e n d o rse d b y th e Ame rica n Me d ica l
As so cia tio n , th e Na tion a l Sa fe ty Co u n cil, a n d th e Ame rica n A sso cia tio n o f Po iso n
Co n trol Ce n te rs. Th e e n tire scre e nin g a n d te stin g p ro ce d u re sh all b e e xpla ine d
to th e te st su b je ct p rio r to th e co n d u ct o f th e scre e nin g te s t.

o Ta ste Th re sh o ld Scre e n in g. Th e Bitre x ta s te th re sh old scre e nin g,

p erfo rme d with o u t we a rin g a re sp ira to r, is in te n de d to d e te rmin e wh e th e r
th e in d ivid u a l b ein g te ste d ca n d e te ct th e t a ste o f Bitre x.

• Du rin g th re sh o ld scre e n in g a s we ll a s d u rin g fit te stin g, su b je cts

sh a ll we a r a n e n clo sure a b o u t th e h e ad a n d sh o uld e rs th a t is
a p pro xima te ly 1 2 in ch e s (30 .5 cm) in d ia me ter b y 1 4 in ch e s (3 5 .6
cm) ta ll. Th e fron t p o rtion o f th e e n clo su re sh a ll b e cle ar fro m th e
re spira tor a n d a llo w fre e mo ve me n t o f th e h e a d wh e n a re sp ira to r
is wo rn . An e n clo su re su b sta n tially similar to th e 3 M h o o d
a sse mb ly, p a rts # FT 1 4 a n d # F T 1 5 co mb in e d , is a d e qu a te .

• Th e te st e n clo su re sh all h a ve a 3 ⁄4 in ch (1 .9 cm) h o le in fro n t o f

th e te st su b je ct's n o se a n d mo u th a re a to a cco m mo d a te th e
n e b ulizer n o zzle .

• Th e te st su b je ct sh a ll d on th e te st e n clo su re . Th ro u gh o u t th e
th re sh o ld scre e nin g te st, th e te st su b je ct s h all bre a th e th rou gh h is
o r h e r sligh tly o p e n mo u th with to n gu e e xte n d e d . Th e su bje ct is
in stru cte d to re p ort wh e n h e /sh e d e te cts a bitte r ta ste .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 14
 • Usin g a De Vilb iss Mo d e l 4 0 In h a la tio n Me d ica tio n Ne b u lize r o r
e qu iva le n t, th e te st co n d u cto r sh a ll sp ra y th e Th re sh old Ch e ck
So lu tio n in to th e e n clo sure . Th is Ne b u lize r sh a ll b e cle arly ma rke d
to distin gu ish it fro m th e fit te st so lu tio n n e b ulize r.

• Th e Th re sh o ld Ch e ck So lu tio n is p re p a re d b y a d din g 1 3 .5
milligra ms o f Bitre x to 1 0 0 ml o f 5 % sa lt (N a Cl) solu tio n in d istilled
wa te r.

• To p ro du ce th e a e ro so l, th e ne b u lize r b u lb is firmly s qu e e ze d so
th a t th e b ulb co lla p se s co mp le tely, a n d is t h e n re le a se d an d
allo we d to fu lly e xp a n d .

• An in itia l te n squ e e ze s a re re p e a te d ra p idly a n d th e n th e te st

su b je ct is a ske d wh e th e r th e Bitre x ca n b e ta ste d . If th e te st
su b je ct re p o rts ta stin g th e b itte r ta ste d u rin g th e te n s qu e e ze s, th e
scre e nin g te s t is co mp le te d . Th e ta ste th re sh o ld is n o te d a s te n
re ga rdle ss o f th e n u mb e r o f s qu e e ze s a ctu ally co mp le te d .

• If th e first re sp o n se is n e ga tive , te n mo re s qu e e ze s a re re p e a te d
rap idly a n d th e te st su b je ct is a ga in a ske d wh e th e r th e Bitre x is
ta ste d . If th e te st su b je ct re p o rts ta stin g th e bitte r ta ste d u rin g th e
se co n d te n squ e e ze s, th e scre e n in g te st is co mp le te d . Th e ta ste
th re sh o ld is n o te d a s twe n ty re ga rd le ss o f t h e n u mb e r o f squ e e ze s
a ctu a lly co mp le te d .

• If th e se co n d re sp o n se is n e ga tive , te n mo re squ e e ze s a re
rep e a te d rap idly a n d th e te st su b je ct is a ga in a ske d wh e th e r th e
Bitre x is ta ste d . If th e te st su b je ct re po rts t a stin g th e b itte r ta ste
d urin g th e th ird se t o f te n squ e e ze s, th e sc ree n in g te st is
co mp le te d . Th e ta ste th re sh o ld is n o te d a s th irty re ga rd le ss o f th e
n u mb e r o f squ e e ze s a ctu a lly co mp le te d .

• (Th e te st co n d u cto r will ta ke n o te o f th e n u mb e r o f squ e e ze s

re qu ire d to so licit a ta ste re sp o n se .

• (If th e Bitre x is n o t ta ste d a fte r 3 0 squ e e ze s (ste p 1 0 ), th e te st

su b je ct is u n a b le to ta ste Bitre x a n d ma y n o t p erfo rm th e Bitre x fit
te st.

• If a ta ste re sp o n se is e licite d , th e te st su b je ct sh a ll b e a ske d to

ta ke n o te o f th e ta ste fo r re fe re n ce in th e fit te st.

• Co rre ct u se o f th e n e b ulizer me a n s th a t a p p ro xima te ly 1 ml o f

liqu id is u se d a t a time in th e n e bu lize r b o d y.

• Th e n e b ulize r sh all b e th oro u gh ly rin se d in wa te r, sh a ke n to d ry,

a n d re fille d a t le a st e a ch mo rn in g a n d a fte rn o o n o r a t le a st e ve ry
fo ur h o u rs.

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 15
 o Bitre x So lu tio n Ae ro so l Fit Te st Pro ce d u re .

• Th e te st su b je ct ma y n o t e a t, d rin k (e xce p t p la in a ter), smo ke , o r

ch e w gu m fo r 1 5 min u te s b e fo re th e te st.

• Th e fit te st u se s th e sa me e n clo su re a s th a t d e scribe d in 4 . (a )

a b o ve .

• Th e te st su b je ct sh a ll d on th e e n clo su re while we a rin g th e

re spira tor se le cte d . Th e re sp ira to r sh a ll b e p ro p e rly a d ju ste d a n d
e qu ip p e d with a n y typ e p a rticu la te filte r(s).

• A se co n d De Vilbiss Mo d e l 4 0 In h a la tio n Me dica tio n Ne b u lize r o r

e qu iva le n t is u se d to sp ra y th e fit te st so lu t io n in to th e e n clo su re .
Th is n e b ulize r sh all b e cle a rly ma rke d to d i stin gu ish it fro m th e
scre e nin g te s t so lu tio n ne b u lize r.

• Th e fit te st so lu tion is p re p are d b y a d din g 3 3 7 .5 mg o f Bitre x to

2 0 0 ml o f a 5 % sa lt (Na Cl) so lu tio n in wa rm wa te r.

• As b e fo re , th e te st su b je ct sh a ll b rea th e th ro u gh h is o r h er sligh tly

o p e n mo u th with to n gu e e xte n d e d , a n d b e in stru cte d to rep o rt if
h e /sh e ta ste s th e b itte r ta ste o f Bitre x.

• Th e n e b ulize r is in se rte d in to th e h ole in th e fron t o f th e e n clo su re

a n d an in itia l co n ce n tra tio n o f th e fit te st s olu tio n is sp ra ye d in to
th e e n clo su re u sin g th e sa me n u mb e r o f sq u e e ze s (eith e r 1 0 , 20
o r 3 0 s qu e e ze s) b a se d o n th e n u mb e r o f squ e e ze s re qu ire d to
elicit a ta ste re sp o n se a s n o te d d urin g th e scre e nin g te s t.

• Afte r ge n e ra tin g th e a e ro so l, th e te st su b je ct sh a ll be in stru cte d to

p erfo rm th e e xe rcise s in se ctio n I. A. 1 4 . o f th is a p pe n d ix.

• Eve ry 3 0 se co n d s th e a e ro sol co n ce n tra tio n sh a ll b e rep le nish e d

u sin g o n e h a lf th e nu mb e r o f s qu e e ze s u se d in itia lly (e .g. , 5 , 1 0 o r
1 5).

• Th e te st su b je ct sh a ll in d ica te to th e te st c o n d u ctor if a t a n y time

d urin g th e fit te st th e ta ste o f Bitre x is d e te cte d . If th e te st su b je ct
d o e s n o t re p o rt ta stin g th e Bitre x, th e te st is p a sse d .

• If th e ta ste o f Bitre x is d e te cte d , th e fit is d e e me d u n sa tisfa cto ry

a n d th e te st is faile d . A d iffe re n t re spira tor sh a ll b e trie d a n d th e
e n tire te st p ro ce d ure is re pe a te d (ta ste th re sh old scre e n in g a n d fit
te stin g).

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 16
 4. IRRITANT SMOKE (STANNIC CHLORIDE) PROTOCOL

Th is qu a lita tive fit te st u se s a p e rso n 's re s p o n se to th e irrita tin g ch e mica ls re le a se d

in th e “smo ke ” p ro d u ce d b y a sta n n ic ch lorid e ve n tila tio n smo ke tu b e to d e te ct
le a ka ge in to th e re sp ira to r.

o Ge n e ra l Re qu ire me n ts a n d Pre ca u tio n s.

• Th e re spira to r to be te ste d sh a ll b e e qu ip p e d with high e fficie n cy

p articu la te air (H E P A) o r P1 0 0 se rie s filter(s).

• On ly sta n n ic ch lo rid e smo ke tu b e s sh a ll be u se d fo r this p ro to co l.

• No fo rm o f te st e n clo su re o r h o o d for th e te st su b je ct sh a ll b e
u se d .

• Th e smo ke ca n b e irrita tin g to th e e ye s, lu n gs, a n d n a sa l

p a ssa ge s. Th e te st co n d u cto r sh a ll ta ke p re ca u tio n s to min imize
th e te st su b je ct's e xp o su re to irrita n t smo k e . Se n sitivity va rie s,
a n d ce rta in in d ividu a ls ma y re sp o n d to a gr e a ter d e gre e to irrita n t
smo ke . Ca re sh a ll b e ta ke n wh e n p e rformin g th e se n sitivity
scre e nin g ch e cks th a t d e te rmin e wh e th e r th e te st su b je ct ca n
d e te ct irrita n t smo ke to u se o n ly th e min imu m a mo u n t o f s mo ke
n e ce ssa ry to e licit a re sp o n se fro m th e te st su b je ct.

• Th e fit te st sh a ll be p e rforme d in a n a re a with a d e qu a te ve n tila tion

to p re ve n t e xp o su re o f th e p e rso n co n d u ctin g th e fit te st o r th e
b uild-u p o f irritan t smo ke in th e ge n e ra l a tmo sp h e re .

o Se n sitivity S cre e n in g Ch e ck.

• Th e p e rso n to b e te ste d mu st d e mo n stra te his o r h e r a bility to

d e te ct a we a k co n ce n tra tio n o f th e irrita n t smo ke .

• Th e te st o p e ra tor sh a ll bre a k b o th e n d s o f a ve n tila tion smo ke

tu b e co n tain in g sta n n ic ch lo rid e , a n d a tta ch o n e en d o f th e smo ke
tu b e to a lo w flo w a ir p u mp se t to d e liver 2 0 0 milliliters p e r min u te ,
o r a n a sp ira to r squ e e ze b u lb . Th e te st o p e r a tor sh a ll co ve r th e
o th er e n d o f th e smo ke tu b e with a sh o rt p ie ce o f tu b in g to p re ve n t
p o te n tia l in jury fro m th e ja g ge d e n d o f th e smo ke tu b e .

• Th e te st o p e ra tor sh a ll ad vise th e te st su b je ct th a t th e smo ke ca n

b e irrita tin g to th e e ye s, lu n g s, a n d n a sa l p a ssa ge s a n d in stru ct
th e su b je ct to ke e p h is/h e r e ye s clo se d wh ile th e te st is p e rfo rme d .

• Th e te st su b je ct sh a ll b e allo we d to s me ll a we a k co n ce n tra tio n o f

th e irrita n t smo ke b e fo re th e re sp ira to r is d o n n ed to b e co me
fa milia r with its irrita tin g p ro p ertie s a n d to d e termin e if h e /sh e ca n
d e te ct th e irrita tin g p ro p e rtie s o f th e smo ke . Th e te st o p e ra to r
sh a ll ca re fully d ire ct a s ma ll a mo u n t o f th e irrita n t smo ke in th e
te st su b je ct's d ire ctio n to d e te rmin e th a t h e /sh e ca n d e te ct it.

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 o Irrita n t Smo ke Fit Te st Pro ce d u re

• Th e p e rso n be in g fit te ste d sh a ll d o n th e re sp ira to r with o u t

a ssista n ce a n d p e rfo rm th e re qu ire d u se r se al ch e ck(s).

• Th e te st su b je ct sh a ll b e in stru cte d to ke e p h is/h er e ye s clo se d .

• Th e te st o p e ra tor sh a ll dire ct th e stre a m o f irrita n t smo ke fro m th e

smo ke tu b e to wa rd th e fa ce se a l a re a o f th e te st su b je ct, u sin g th e
lo w flo w p u mp o r th e s qu e e ze b u lb . Th e te st o p e ra tor sh a ll b e gin
a t le a st 1 2 in ch e s fro m th e fa ce p ie ce a n d mo ve th e s mo ke stre a m
a ro u n d th e wh o le p erime te r o f th e ma sk. T h e o pe ra to r sh all
gra d u a lly ma ke t wo mo re p a sse s a ro u n d th e p erime te r o f th e
ma sk, mo vin g to with in six in ch e s o f th e re sp ira to r.

• If th e p e rso n be in g te ste d h a s n o t h a d a n in vo lu n ta ry re sp o n se
a n d /or d e te cte d th e irrita n t smo ke , p ro ce e d with th e te st e xe rcise s.

• Th e e xe rcise s id en tified in se ctio n I.A. 1 4 . o f th is a p pe n d ix sh a ll

b e p erfo rme d b y th e te st su b je ct wh ile th e re spira tor se a l is b ein g
co n tinu a lly ch a lle n ge d b y th e smo ke , d ire cte d aro u n d th e
p erime te r o f th e re spira tor a t a d ista n ce o f six in ch e s.

• If th e p e rso n be in g fit te ste d re p o rts d e te ctin g th e irritan t s mo ke a t

a n y time , th e te st is fa iled . Th e p e rso n b e in g re te ste d mu st re p e a t
th e e n tire se n sitivity ch e ck a n d fit te st p ro c e d ure .

• Ea ch te st su b je ct p a ssin g th e irrita n t smo k e te st with o u t e vid e n ce

o f a re sp on se (in volu n ta ry co u gh , irrita tio n) sh a ll b e give n a
se co n d se n sitivity scre e nin g ch e ck, with th e smo ke fro m th e sa me
smo ke tu b e u se d d u rin g th e fit te st, o n ce t h e re sp ira tor h a s b e e n
re mo ve d , to d e te rmine wh e th e r h e /sh e still rea cts to th e s mo ke .
Fa ilu re to e vo ke a re sp o n se sh all vo id th e fit te st.

• If a re sp o n se is p ro d u ce d d urin g th is se co n d se n sitivity ch e ck,

th e n th e fit te st is p a sse d .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 18
 8.0 Quantitative Fit Test (QNFT) Protocols
Th e fo llo win g qu a n tita tive fit te stin g p ro ce d u re s h a ve b e e n d e mo n stra te d to b e
a cce p ta b le : Qu a n tita tive fit te stin g u sin g a n o n-h a za rd ou s te st a e ro so l (su ch a s co rn
oil, p olye th yle n e glyco l 4 0 0 [P E G 4 0 0 ], d i-2 -e th yl h e xyl se b a ca te [D E H S], o r so d iu m
ch lorid e) ge n e ra te d in a te st ch a mb e r, a n d e mp lo yin g in stru me n ta tio n to qu a n tify th e
fit o f th e re sp ira to r; Qu a n tita tive fit te stin g u sin g a mb ie n t a e ro sol a s th e te st a ge n t
a n d ap p ro pria te in stru me n ta tio n (co nd e n sa tion n u clei co u n te r) to qu a n tify th e
re spira tor fit; Qu a n tita tive fit te stin g u sin g co n trolled n e ga tive p re ssu re a n d
a p pro p ria te in stru me n ta tio n to me a su re th e vo lu me tric le a k ra te o f a fa ce p ie ce to
qu a n tify th e re sp ira to r fit.

GENERAL

Th e e mp lo ye r sh all e n su re tha t p e rso n s a d min isterin g QN FT a re a b le to ca lib ra te

e qu ip me n t a n d p e rform te st s p ro p erly, re co gn ize in va lid te sts, ca lcu la te fit fa cto rs
p ro p e rly a n d e n su re th a t te st e qu ip me n t is in p ro p er wo rkin g o rd e r.

Th e e mp lo ye r sh all e n su re tha t QN FT e qu ip me n t is ke p t cle a n , a n d is ma in ta in e d

a n d calibra te d a cco rd in g to th e ma n u fa ctu r e r's in stru ctio n s so a s to o p e ra te a t th e
p ara me te rs fo r wh ich it wa s d e sign e d .

1. GENERATED AEROSOL QUANTITATIVE FIT TESTING PROTOCOL

o Ap p a ra tu s.

• In stru me n ta tio n . Ae ro so l ge n e ra tio n , d ilu tio n , a n d me a su re me n t

syste m s u sin g p a rticu la te s (co rn oil, p olye th ylen e glyco l 4 0 0 [ P E G
4 0 0 ], di-2-e th yl h e xyl se b a ca te [D EH S] o r so diu m ch lo rid e ) a s te st
a ero so ls sh a ll b e u se d fo r qu a n tita tive fit te stin g.

• Te st ch a mb e r. Th e te st ch a mb e r sh a ll b e la rge e n o u gh to p e rmit
all te st su b je cts to p e rfo rm fre ely a ll re qu ire d e xe rcise s with o u t
distu rb in g th e te st a ge n t co n ce n tra tio n or th e me a su re me n t
a p p ara tu s. Th e te st ch a mb e r sh a ll b e e qu ip p e d an d co n stru cte d so
th a t th e te st a ge n t is e ffe ctive ly iso la te d fro m th e a mb ie n t a ir, ye t
u nifo rm in co n ce n tra tio n th ro u gh o u t th e ch a mb e r.

• W h e n te stin g a ir-p urifyin g re sp ira to rs, th e n orma l filter o r ca rtrid ge

ele me n t sh a ll b e re p la ce d with a high e ffici e n cy p a rticu la te air
(HE P A) o r P1 0 0 se rie s filter su p p lie d b y th e sa me ma n u fa ctu re r.

• Th e sa mp lin g in stru me n t sh a ll b e sele cte d so th a t a co mp u te r

re cord o r strip ch a rt re co rd ma y b e ma d e o f th e te st sh o win g th e
rise a n d fa ll o f th e te st a ge n t co n ce n tra tion with e a ch in spira tio n
a n d e xpira tio n a t fit fa cto rs o f a t le a st 2 ,0 0 0 . In te gra to rs o r
co mp u te rs th a t in te gra te th e a mo u n t o f te st a ge n t p e n e tra tio n
le a ka ge in to th e re sp ira to r fo r e a ch e xercis e ma y b e u se d p ro vid e d
a re co rd o f th e re ad in gs is ma d e .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 19
 • Th e co mb in a tio n o f su b stitu te air-p u rifyin g ele me n ts, te s t a ge n t
a n d te st a ge n t co n ce n tra tio n sh a ll b e su ch th a t th e te st su b je ct is
n o t e xp o se d in e xce ss o f a n e sta b lish e d e x p o su re limit for th e te st
a ge n t a t a n y time d u rin g th e te stin g p ro ce s s, b a se d u p o n th e
le n gth o f th e e xp o su re a n d th e e xp o su re limit d u ra tio n .

• Th e sa mp lin g p o rt o n th e te st sp e cime n re s pira to r sh all b e pla ce d

a n d co n stru cte d so th a t n o le a ka ge o c cu rs a ro u n d th e p ort (e .g.,
wh e re th e re sp ira to r is p ro b e d ), a fre e a ir flo w is a llo we d in to th e
sa mp lin g line a t a ll time s, a n d th e re is n o in terfe re n ce with th e fit
o r p e rfo rma n ce o f th e re spira tor. Th e in -ma sk sa mp lin g d e vice
(pro b e) sh a ll be d e sign e d a n d u se d so th a t th e air sa mp le is d ra wn
fro m th e b rea th in g zo n e o f th e te st su b je ct, mid wa y b e twe e n th e
n o se a n d mo u th a n d with th e pro b e e xte n d in g in to th e fa ce p ie ce
ca vity a t le a st 1 ⁄4 in ch .

• Th e te st se tu p sh a ll p ermit th e p e rso n a d min iste rin g th e te st to

o b se rve th e te st su b je ct in sid e th e ch a mb e r du rin g th e te st.

• Th e e qu ip me n t ge n e ra tin g th e te s t a tmo sp h ere sh a ll ma in ta in th e

co n ce n tra tio n o f te st a ge n t co n sta n t to with in a 1 0 p e rce n t
va ria tio n for th e d u ra tio n o f th e te st.

• Th e time la g (in terva l b e twe e n a n e ve n t a n d th e re co rd in g o f th e

e ve n t o n th e strip ch a rt o r co mp u te r o r in te gra to r) sh all b e ke p t to
a min imu m. Th e re sh a ll be a cle a r a sso cia tio n b e twe e n th e
o ccu rre n ce o f a n e ve n t a n d its b e in g re co r d e d .

• Th e sa mp lin g lin e tu bin g fo r th e te st ch a mb e r a tmo sp h e re a n d fo r

th e re sp ira tor sa mp lin g p o rt sh a ll be o f e qu al d ia me te r a n d o f th e
sa me ma te ria l. Th e len gth o f th e t wo lin e s sh a ll b e e qu a l.

• Th e e xh a u st flo w fro m th e te st ch a mb e r sh all p a ss th ro u gh a n

a p pro p ria te filte r (i.e ., h igh e fficie n cy p a rtic ula te filte r) b e fore
rele a se .

• W h e n so d iu m ch lo rid e a e ro so l is u se d , th e rela tive h u midity in sid e

th e te st ch a mb e r sh a ll no t e xce e d 5 0 p e rce n t.

• Th e limita tio n s o f in stru me n t d e te ction sh a ll be ta ke n in to a cco u n t

wh e n d e te rminin g th e fit fa cto r.

• Te st re sp ira to rs sh a ll be ma in ta in ed in p ro p er wo rkin g o rd e r a n d
b e in sp e cte d re gu la rly fo r d e ficien cie s su c h a s cra cks o r missin g
va lve s a n d ga ske t s.

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 20
 o Pro ce d u ral Re qu ire me n ts.

• W h e n p e rformin g th e in itial u se r se a l ch e ck u sin g a p o sitive o r

n e ga tive p re ssu re ch e ck, th e sa mp lin g lin e sh a ll b e crimp e d clo se d
in o rd er to a vo id a ir p re ssu re le a ka ge d u rin g e ith e r o f th e se
p re ssu re ch e cks.

• Th e u se o f a n a b b re via te d scre e nin g QL FT te st is o p tio na l. Su ch a

te st ma y b e u tilize d in o rd er to qu ickly id e n tify p o or fittin g
re spira tors th a t p a sse d th e p o sitive a n d /o r n e ga tive p re ssu re te st
a n d re d u ce th e a mo u n t o f QNF T time . Th e u se o f th e CN C QN FT
in stru me n t in th e co u n t mo d e is a n o th e r o p tion a l me th o d to o b tain
a qu ick e stima te o f fit a n d e limin a te po o r fittin g re sp ira to rs b e fo re
go in g o n to p e rfo rm a fu ll QN FT.

• A re a so n a b ly sta b le te st a ge n t co n ce n tra tio n sh all b e me a su re d in

th e te st ch a mb e r p rio r to te stin g. Fo r ca n o p y o r sh o we r cu rtain
typ e s o f te st u n its, th e d e te rmin a tio n o f th e te st a ge n t's sta b ility
ma y b e e sta b lish e d a fter th e te st su b je ct h a s e n te re d th e te st
e n viro n me n t.

• Imme d ia te ly a fte r th e su bje ct e n te rs th e te st ch a mb e r, th e te st

a ge n t co n ce n tra tio n in sid e th e re sp ira tor s h all b e me a su re d to
e n su re th a t th e p e a k p e n e tra tio n d o e s n o t e xce e d 5 p e rce n t for a
h alf ma s k o r 1 p e rce n t for a fu ll fa ce p ie ce re sp ira to r.

• A sta b le te st a ge n t co n ce n tra tio n sh a ll b e o b tain e d prio r to th e

a ctu a l sta rt o f te stin g.

• Re sp ira tor re strain in g stra p s sh a ll n o t b e o ve r-tigh te n e d fo r

te stin g. Th e stra p s sh a ll b e a d ju ste d b y th e we a rer with o u t
a ssista n ce fro m o th e r p erso n s to give a re a so n a bly co mfo rta b le fit
typ ica l o f n o rma l u se . Th e re sp ira to r sh a ll n o t b e a dju ste d o n ce
th e fit te st e xe rcise s b e gin .

• Th e te st sh a ll b e termin a te d wh e n e ve r a n y sin gle p e a k p e n e tra tio n

e xce e d s 5 p e rce n t fo r ha lf ma sk s a n d 1 p e rce n t fo r full fa ce p ie ce
re spira tors. Th e te st su b je ct sh a ll b e re fitte d a n d re te ste d .

• Ca lcu la tio n o f fit fa cto rs.

o Th e fit fa cto r sh a ll b e d e termin e d fo r th e q u a n tita tive

fit te st b y ta kin g th e ra tio o f th e a ve ra ge ch a mb e r
co n ce n tra tio n to th e co n ce n tra tio n me a su re d in sid e
th e re sp ira tor fo r e a ch te st e xe rcise e xce p t th e
grima ce e xe rcise .

o Th e a ve ra ge te st ch a mb e r co n ce n tra tio n sh all b e

ca lcula te d a s th e a rith me tic a ve ra ge o f th e
co n ce n tra tio n me a su re d b e fore a n d a fte r e a ch te st
(i.e ., 7 e xe rcise s) o r the a rith me tic a ve ra ge o f th e
Re spira tory Fit Te stin g Po licy & Pro ce dure s
O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 21
 co n ce n tra tio n me a su re d b e fore a n d a fte r e a ch
e xe rcise or th e tru e a ve ra ge me a su re d co n tinu o u sly
d urin g th e re sp ira to r sa mp le .

o Th e co n ce n tra tio n o f th e ch a lle n ge a ge n t in side th e re sp ira to r sh all

b e d e termin e d b y o n e o f th e follo win g me th o d s:

• Ave ra ge p e a k p e n e tra tio n me th o d me a n s t h e me th o d o f

d e termin in g te st a ge n t p e n e tra tio n in to th e re spira tor u tilizin g
a strip ch a rt re co rd e r, in te gra to r, or co mp u t e r. Th e a ge n t
p e n e tra tion is d e te rmin e d b y a n a vera ge o f th e p e a k h eigh ts
o n th e gra p h or b y co mp u te r in te gra tio n , fo r ea ch e xe rcise
e xce p t th e grima ce e xe rcise . In te gra to rs o r co mp u te rs th a t
ca lcula te th e a ctu a l te st a ge n t p e n e tra tio n in to th e re sp ira tor
fo r ea ch e xe rcise will also b e co n sid ere d to me e t th e
re qu ire me n ts o f th e a ve ra ge p e a k p e n e tra tio n me th o d .

• Ma ximu m p e a k p e n e tra tio n me th o d me a n s th e me th o d o f

d e termin in g te st a ge n t p e n e tra tio n in th e re sp ira to r a s
d e termin e d b y strip ch a rt re co rd in g s o f th e te st. Th e h igh e st
p e a k p e n e tra tion fo r a give n e xe rcise is ta k e n to b e
rep re se n ta tive o f a ve ra ge p e n e tra tio n in to th e re sp ira tor fo r
th a t e xe rcise .

• In te gra tio n b y ca lcula tio n o f th e are a u n d er th e in d ividu a l

p e a k fo r ea ch e xe rcise e xce p t th e grima ce e xe rcise . Th is
in clu d e s co mp u te rize d in te gra tio n .

• Th e ca lcu la tio n o f th e o ve rall fit fa cto r u sin g in d ividu a l

e xe rcise fit fa cto rs in vo lve s first co n ve rtin g th e e xe rcise fit
fa cto rs to p e n e tra tio n va lu e s, d e te rmin in g t h e a ve ra ge , a n d
th e n co n ve rtin g th a t re su lt b a ck to a fit fa ct o r. This p ro ce d u re
is d e scrib e d in the fo llo win g e qu a tio n :

W h e re ff 1 , ff 2 , ff 3 , e tc. a re th e fit fa cto rs fo r e xe rcise s 1 , 2 , 3 , e tc.

• Th e te st su b je ct sh a ll n o t be p e rmitte d to w e ar a h a lf ma sk o r
qu a rte r fa ce pie ce re sp ira to r u nle ss a min imu m fit fa cto r o f 1 0 0
is o b tain e d , or a fu ll fa ce pie ce re sp ira to r u nle ss a minimu m fit
fa cto r o f 5 0 0 is o b ta in e d .

• Filte rs u se d fo r qu a n tita tive fit te stin g sh a ll b e re p la ce d

wh e n e ve r in cre a se d b rea th in g re sista n ce is e n co u n tere d , o r
wh e n th e te st a ge n t h a s a lte re d th e in te grity o f th e filte r me d ia .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 22
2. AMBIENT AEROSOL CONDENSATION NUCLEI COUNTER (CNC) QUANTITATIVE FIT
TESTING PROTOCOL.

Th e a mb ie n t a ero so l co n d e n sa tio n n u clei c o u n ter (CNC) qu a n tita tive fit te stin g

(Po rta Co u n t®) p ro to co l qu a n tita tive ly fit te sts re sp ira to rs with th e u se o f a p ro b e .
Th e p rob e d re sp ira to r is o n ly u se d fo r qu a n tita tive fit te sts. A p ro b e d re spira to r h a s a
sp e cial sa mp lin g d e vice , in sta lled o n th e re sp ira to r, th a t allo ws th e p ro b e to sa mp le
th e air fro m in sid e th e ma sk. A p ro b e d re sp ira to r is re qu ire d fo r e a ch ma ke , style ,
mo d e l, a n d size th a t th e e mp lo ye r u se s a n d ca n b e o b tain e d fro m th e re spira tor
ma n u fa ctu re r or d istrib u to r. Th e prima ry C NC in stru me n t ma n u fa ctu re r, T SI
In co rp ora te d , also p ro vid e s p ro b e a tta ch m e n ts (TSI ma sk sa mp lin g a d a p te rs) th a t
p ermit fit te stin g in a n e mp lo ye e 's o wn re s pira to r. A min imu m fit fa cto r p a ss le ve l o f
a t le a st 1 0 0 is n e ce ssa ry fo r a h a lf-ma s k re sp ira to r (e la sto me ric o r filterin g
fa ce p ie ce ), a n d a min imu m fit fa cto r p a ss le ve l o f a t le a st 5 0 0 is re qu ire d fo r a fu ll-
fa ce p ie ce e la sto me ric re spira to r. Th e e n tire scre e nin g a n d te stin g p ro ce d u re sh a ll b e
e xp la in e d to th e te st su b je ct p rio r to th e co n d u ct o f th e scre e nin g te st.

o Po rta Co u n t ® Fit Te st Re qu ire me n ts.

• Ch e ck th e re sp ira tor to ma ke su re th e sa m plin g p ro b e a n d lin e

a re p ro p erly a tta ch e d to th e fa ce p ie ce a n d th a t th e re sp ira tor is
fitte d with a pa rticula te filte r ca p a b le o f p re ve n tin g sign ifica n t
p e n e tra tion b y th e a mb ie n t p a rticle s u se d f o r the fit te st (e .g.,
NI O SH 4 2 CFR 8 4 se rie s 1 0 0 , se rie s 9 9 , o r se rie s 9 5
p articu la te filter) p e r ma n u fa ctu rer's in stru ction .

• In stru ct th e p e rso n to b e te ste d to d o n the re spira tor fo r five

min u te s b e fo re th e fit te st sta rts. Th is p u r g e s th e a mb ie n t
p article s tra pp e d in sid e th e re sp ira to r an d p ermits th e we a re r to
ma ke ce rta in th e re sp ira tor is co mfo rta b le . Th is ind ivid ua l sh a ll
alre a d y h a ve b e e n tra in ed o n h o w to we a r t h e re sp ira tor
p ro p e rly.

• Ch e ck th e fo llo win g co n d itio n s for th e a d e q u a cy o f th e

re spira tor fit: Ch in p rop e rly p la ce d ; Ad e qu a te stra p te n sio n , n o t
o ve rly tigh te n e d ; Fit a cro ss n o se b rid ge ; R e sp ira to r o f pro p e r
size to sp a n d ista n ce fro m n o se to ch in ; Te n d e n cy o f th e
re spira tor to slip ; Se lf-o b se rva tio n in a mirro r to e valu a te fit a nd
re spira tor p o sitio n .

• Ha ve th e p e rso n we a rin g th e re sp ira to r do a u se r se al ch e ck. If

le a ka ge is d e te cte d , d e te rmin e th e ca u se . I f lea ka ge is fro m a
p o orly fittin g fa ce p ie ce , try a n o th er size o f th e sa me mo d e l
re spira tor, o r a n o th er mo d e l o f re spira tor.

• Fo llo w th e ma n u fa ctu re r's in stru ctio n s fo r o p era tin g th e

Po rta co u n t ® a n d p ro ce e d with th e te st.

• Th e te st su b je ct sh a ll b e in stru cte d to p e rfo rm th e e xe rcise s a s

in d ica te d fo r this p ro ce d ure .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 23
 • Afte r th e te st e xe rcise s, th e te st su b je ct sh all b e qu e stio n e d b y
th e te st co n d u cto r re ga rdin g th e co mfo rt o f th e re spira tor u p o n
co mp le tion o f th e p ro to co l. If it ha s b e co me u n a cce p ta ble ,
a n o the r mo d e l o f re spira tor sh a ll be trie d .

o Po rta Co u n t ® Te s t In stru me n t.

• Th e Po rta Co u n t ® will a u to ma tica lly sto p a n d ca lcula te th e

o ve rall fit fa cto r fo r th e e n tire se t o f e xe rcise s. Th e o ve ra ll fit
fa cto r is wh a t co u n ts. Th e Pa ss o r Fa il me s sa ge will in dica te
wh e th e r or n o t th e te st wa s su cce s sfu l. If t h e te st wa s a Pa ss ,
th e fit te st is o ve r.

• Sin ce th e p a ss o r fa il crite rio n o f th e Po rta Co u n t® is u se r

p ro gra m ma b le , th e te st o p e ra tor sh a ll en su re tha t th e p a ss o r
fa il criterion me e t th e re qu ire me n ts fo r min imu m re sp ira tor
p erfo rma n ce in th is Ap p e n d ix.

• A re co rd o f th e te st n e e d s to b e ke p t o n file , a ssu min g th e fit

te st wa s su cce ssfu l. Th e re co rd mu st co n ta in th e te st su b je ct's
n a me ; o ve rall fit fa cto r; ma ke , mo d e l, style , a n d size o f
re spira tor u se d ; a n d d a te te ste d .

3. MODIFIED AMBIENT AEROSOL CONDENSATION NUCLEI COUNTER (CNC)

QUANTITATIVE FIT TESTING PROTOCOL FOR FULL-FACEPIECE AND HALF-
MASK ELASTOMERIC RESPIRATORS.

o W h e n a d min iste rin g th is p ro to co l to te st su bje cts, e mp lo ye rs sh a ll co mp ly with

th e re qu ire me n ts sp e cifie d in th e a mb ien t a e ro so l co n d e n sa tion n u cle i co u n te r
(CNC) qu a n tita tive fit te stin g p ro to co l, e xce p t th e y sh a ll u se th e te st e xe rcise s
d e scrib e d b e lo w in ste a d o f th e o th e r te st e xe rcise s sp e cified .

o (b) E mp lo ye rs sh a ll e n su re th a t e a ch te st s u bje ct b e in g fit te ste d u sin g th is

p ro to co l fo llo ws th e e xe rcise a n d d u ra tio n p ro ce d u re s, in clu d in g th e o rd er o f
a d ministra tio n .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 24
Table A-1 - Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for Full
Facepiece and Half-Mask Elastomeric Respirators

Measurement
Exercises 1
Exercise procedure procedure

Be n d in g Th e te st su b je ct sh a ll b en d a t th e A 2 0 se co n d a mb ie n t
Ove r wa ist, a s if go in g to to u ch h is/h e r sa mp le , fo llo we d b y a 3 0
to e s fo r 5 0 se co n d s a n d in h a le 2 se co n d ma sk sa mp le .
time s a t th e b o tto m 2

Jo g gin g-in - Th e te st su b je ct sh a ll jo g in p la ce A 3 0 se co n d ma sk
Pla ce co mfo rta b ly fo r 3 0 se co n d s sa mp le .

He a d Sid e - Th e te st su b je ct sh a ll sta n d in A 3 0 se co n d ma sk
to -Sid e pla ce , slo wly tu rn in g h is/h e r h e ad sa mp le .
fro m sid e to sid e for 3 0 se co n d s
a n d in h ale 2 time s a t e a ch
e xtre me 2

He a d Up - Th e te st su b je ct sh a ll sta n d in A 3 0 se co n d ma sk
a n d-Do wn pla ce , slo wly mo vin g h is/h e r h e a d sa mp le fo llo we d b y a 9
u p a nd d o wn fo r 3 9 se co n d s a n d se co n d a mb ie n t sa mp le .
in h a le 2 time s a t e a ch e xtre me 2

1
E xe rcise s a re liste d in th e ord e r in wh ich th e y a re to be a d min iste red .
2
It is o p tio n al fo r te st su b je cts to ta ke a d d itio n a l bre a th s a t o th e r time s d u rin g th is e xe rcise .

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4. MODIFIED AMBIENT AEROSOL CONDENSATION NUCLEI COUNTER (CNC)
QUANTITATIVE FIT TESTING PROTOCOL FOR FILTERING FACEPIECE
RESPIRATORS.

o W h e n a d min iste rin g th is p ro to co l to te st su bje cts, e mp lo ye rs sh a ll co mp ly with

th e re qu ire me n ts sp e cifie d in Pa rt I.C.3 o f t his a p p e n d ix (a mb ie n t a e ro sol
co n d e n sa tio n n u clei co u n te r (CNC) qu a n tita tive fit te stin g p ro to co l), e xce p t th e y
sh a ll u se th e te st e xe rcise s d e scrib e d b elo w in p ara gra p h (b ) o f this p ro to co l
in ste a d o f th e te st e xe rcise s sp e cifie d in se ctio n I.C.3 (a )(6 ) o f this a p p e n dix.

o (b) E mp lo ye rs sh a ll e n su re th a t e a ch te st s u bje ct b e in g fit te ste d u sin g th is

p ro to co l fo llo ws th e e xe rcise a n d d u ra tio n p ro ce d u re s, in clu d in g th e o rd er o f
a d ministra tio n , de scrib e d in Ta b le A-2 o f th is a p pe n d ix.

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 26
Table A-2 - Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for
Filtering Facepiece Respirators

Exercise Measurement
Exercises 1
procedure procedure

Be n d in g Th e te st su b je ct sh a ll b en d a t th e A 2 0 se co n d a mb ie n t
Ove r wa ist, a s if go in g to to u ch h is/h e r sa mp le , fo llo we d b y a
to e s fo r 5 0 se co n d s a n d in h a le 2 3 0 se co n d ma sk
time s a t th e b o tto m 2 sa mp le .

Ta lkin g Th e te st su b je ct sh a ll talk o u t lo u d A 3 0 se co n d ma sk
slo wly a n d lo u d e n o u gh so a s to b e sa mp le .
h e ard cle arly b y th e te st co n d u cto r fo r
3 0 se co n d s. He /sh e will e ithe r re ad
fro m a p rep a re d te xt su ch a s th e
Ra in b o w Pa s sa ge , co u n t b a ckwa rd
fro m 1 0 0 , o r re cite a me mo rize d p o e m
o r so n g

He a d Sid e - Th e te st su b je ct sh a ll sta n d in p la ce , A 3 0 se co n d ma sk
to -Sid e slo wly tu rnin g h is/h e r h e a d fro m sid e sa mp le .
to sid e for 3 0 se co n d s a n d in h ale 2
time s a t e a ch e xtre me 2

He a d Up - Th e te st su b je ct sh a ll sta n d in p la ce , A 3 0 se co n d ma sk
a n d-Do wn slo wly mo vin g h is/h e r h e a d u p a n d sa mp le fo llo we d b y a
d o wn fo r 3 9 se co n d s a n d in h a le 2 9 se co n d a mb ie n t
time s a t e a ch e xtre me 2 sa mp le .

1
E xe rcise s a re liste d in th e ord e r in wh ich th e y a re to be a d min iste red .
2
It is o p tio n al fo r te st su b je cts to ta ke a d d itio n a l bre a th s a t o th e r time s d u rin g th is e xe rcise .

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 27
5. CONTROLLED NEGATIVE PRESSURE ( CNP) QUANTITATIVE FIT TESTING
PROTOCOL.

o Th e CN P p ro to co l p ro vide s a n a lte rn a tive to a ero so l fit te st me th o d s. Th e CN P

fit te st me th o d te ch n o lo gy is b a se d o n e xh a u stin g a ir fro m a te mp o ra rily se a le d
re spira tor fa ce p ie ce to ge n e ra te a n d th e n ma in tain a co n sta n t n e ga tive p re ssu re
in sid e th e fa ce p ie ce .

o Th e ra te o f air e xh a u st is co n trolle d so th a t a co n sta n t n e ga tive p re ssu re is

ma in tain e d in the re sp ira to r d urin g th e fit t e st. Th e le ve l o f pre ssu re is se le cte d to
rep lica te th e me a n in sp ira tory p re ssu re th a t ca u se s le a ka ge in to th e re sp ira to r u n de r
n orma l u se co n d ition s.

o W ith p re ssu re he ld co n sta n t, a ir flo w o u t o f th e re spira tor is e qu a l to a ir flo w

in to th e re sp ira to r. Th e re fo re , me a su re me n t o f th e e xh a u st stre a m th a t is re qu ire d to
h old th e p re ssu re in th e te mp o rarily se a le d re spira tor co n sta n t yie ld s a d ire ct
me a su re o f lea ka ge a ir flo w in to th e re spira tor.

o Th e CN P fit te st me th o d me a su re s le a k ra te s th ro u gh th e fa ce p ie ce a s a
me th o d fo r d e termin in g th e fa ce p ie ce fit fo r n e ga tive p re ssu re re sp ira tors. Th e C N P
in stru me n t ma n u fa ctu re r Occu p a tio n a l He alth Dyn a mics o f Birmin gh a m, Ala b a ma a lso
p ro vid e s a tta ch me n ts (sa mp lin g ma n ifo ld s) th a t rep la ce th e filte r ca rtrid ge s to p e rmit
fit te stin g in a n e mp lo ye e 's o wn re sp ira to r.

o To p e rform th e te st, th e te st su b je ct clo se s h is or h e r mo u th a n d h old s h is/h e r

b re a th , a fte r wh ich a n air p u mp re mo ve s a ir fro m th e re sp ira tor fa ce p ie ce a t a pre -
se le cte d co n sta n t p re ssu re . Th e fa ce pie ce fit is e xp re sse d a s th e le a k ra te th rou gh
th e fa ce pie ce , e xp re sse d a s milliliters p e r min u te .

o Th e qu a lity a n d va lid ity o f th e CN P fit te st s a re d e te rmin e d b y th e d e gre e to

wh ich th e in-ma sk p re ssu re tra cks th e te s t p re ssu re d u rin g th e s yste m me a su re me n t
time o f a p pro xima te ly five se co n d s. In sta n t a n e ou s fe e d b a ck in th e fo rm o f a re a l-time
p re ssu re tra ce o f th e in-ma sk p re ssu re is p ro vid e d a n d u se d to d e termin e te st va lidity
a n d qu a lity.

o A min imu m fit fa cto r p a ss le ve l o f 1 0 0 is n e ce ssa ry fo r a h a lf-ma sk re sp ira to r

a n d a minimu m fit fa c to r o f a t lea st 5 0 0 is re qu ire d for a fu ll fa ce p ie ce re spira tor. Th e
e n tire scre e nin g a n d te stin g p ro ce d u re sh a ll b e e xp la in e d to th e te st su b je ct p rio r to
th e co n d u ct o f th e scre e n in g te st.

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 28
 o CN P Fit Te st Re qu ire me n ts.

• Th e in stru me n t sh a ll h a ve a n o n-a d ju sta ble te st p re ssu re o f 1 5 .0

mm wa te r p re ssu re .

• Th e CN P syste m d e fa u lts se le cte d fo r te st p re ssu re sh a ll be se t a t

−1 5 mm o f wa te r (-0 .5 8 in ch e s o f wa te r) a n d th e mo d e led
in sp ira tory flo w ra te sh a ll b e 5 3 .8 lite rs p e r min u te fo r pe rfo rmin g
fit te sts.

No te : C N P sy ste ms h a ve b u ilt-in ca p a b ility to co n d u ct fit te stin g

th a t is sp e cific to u n iqu e wo rk ra te , ma sk, a n d ge n d e r situa tio n s
th a t migh t a p p ly in a sp e cific wo rkp la ce . Use o f syste m d e fa u lt
va lue s, wh ich we re se le cte d to re p re se n t re sp ira to r we a r with
me d iu m ca rtrid ge re sista n ce a t a lo w-mo d e ra te wo rk ra te , will
allo w in ter-te st co mp a riso n o f th e re sp ira to r fit.)

• Th e in divid u al wh o co n d u cts th e C N P fit te stin g sh a ll b e th oro u gh ly

train e d to p erfo rm th e te st.

• Th e re spira to r filter o r ca rtrid ge n e e d s to b e re p la ce d with th e CN P

te st ma n ifo ld . Th e inh a la tio n va lve d o wn stre a m fro m th e ma n ifo ld
eith e r n e ed s to b e te mp o ra rily re mo ve d o r p ro p p e d o p en .

• Th e e mp lo ye r mu st tra in th e te st su b je ct to h old h is o r he r b rea th

fo r a t le a st 1 0 se co n d s.

• Th e te st su b je ct mu st d o n th e te st re sp ira to r witho u t a n y
a ssista n ce fro m th e te st a d min istra to r wh o is co n d u ctin g th e CN P
fit te st. Th e re sp ira to r mu st n o t b e a d ju ste d o n ce th e fit-te st
e xe rcise s b e gin . An y a d ju stme n t vo id s th e te st, a n d th e te st
su b je ct mu st re p e a t th e fit te st.

• Th e Q NF T p ro to co l sh all b e follo we d a cco rdin g to se ctio n I. C. 1 .

o f th is a p pe n d ix with a n e xce p tio n for th e CN P te st e xe rcise s.

o CN P Te st Exe rcise s.

• No rma l b re a th in g. In a n o rma l sta n d in g p o s itio n , with o u t ta lkin g,

th e su b je ct sh a ll b re a th e n o rma lly fo r 1 min u te . Afte r th e n o rma l
b re a th in g e xe rcise , th e su b je ct n e e d s to h o ld h e a d stra igh t a h e a d
a n d ho ld his o r h e r bre a th fo r 1 0 se co n d s d u rin g th e te st
me a su re me n t.

• De e p b rea th in g. In a n o rma l sta n d in g p o sitio n , th e su bje ct sh a ll

b re a th e slo wly a n d d e e ply fo r 1 min u te , b ein g ca re fu l n o t to
h yp e rve n tila te . Afte r th e d e e p b re a th in g e x e rcise , th e su b je ct sh a ll
h old h is o r he r h e a d straigh t a h e a d a n d h o ld his o r h e r bre a th fo r
1 0 se co n d s d u rin g te st me a su re me n t.

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O w n e r: Cli n ic a l G o v e r n a n c e 2 0 2 4 29
 • Tu rnin g h e a d sid e to sid e . Sta n d in g in p la ce , th e su b je ct sh a ll
slo wly tu rn his o r h er h e a d fro m sid e to sid e b e twe e n th e e xtre me
p o sitio n s o n e a ch sid e for 1 min u te . Th e h e a d sh all b e h eld a t
e a ch e xtre me mo me n ta rily so th e su b je ct c a n in h a le a t e a ch sid e .
Afte r th e tu rn in g h e a d sid e to side e xe rcise , th e su b je ct n e e d s to
h old h e a d full le ft a n d h o ld his o r h er b re a th fo r 10 se co n d s d u rin g
te st me a su re me n t. Ne xt, th e su b je ct n e e d s to h old h e a d full righ t
a n d ho ld his o r h e r bre a th fo r 1 0 se co n d s d u rin g te st
me a su re me n t.

• Mo vin g h e a d u p a n d d o wn . Sta n d in g in p la ce , th e su b je ct sh a ll
slo wly mo ve h is o r h e r he a d u p a n d d o wn fo r 1 min u te . Th e su b je ct
sh a ll b e in stru cte d to in h ale in th e u p p o sitio n (i.e ., wh e n lo o kin g
to wa rd th e ce ilin g). Afte r th e mo vin g h e a d u p a nd d o wn e xe rcise ,
th e su b je ct sh a ll h old h is o r he r h e a d full u p a n d ho ld his o r h e r
b re a th fo r 1 0 se co n d s d u rin g te st me a su re me n t. Ne xt, th e su b je ct
sh a ll h o ld h is o r h er h e a d full d o wn a n d h old his o r h e r bre a th fo r
1 0 se co n d s d u rin g te st me a su re me n t.

• Ta lkin g. Th e su b je ct sh a ll talk o u t lo u d slo wly a n d lou d e n o u gh so

a s to b e h e ard cle a rly b y th e te st co n d u cto r. Th e su b je ct ca n re a d
fro m a p rep a re d te xt su ch a s th e Ra in b o w Pa ssa ge , co u n t
b a ckwa rd fro m 1 0 0 , o r re cite a me mo rize d p o e m o r so n g fo r 1
min u te . Afte r th e ta lkin g e xe rcise , th e su b je ct sh a ll h o ld his o r h e r
h e a d stra igh t a h e a d a n d h old h is o r h er b re a th fo r 1 0 se co n d s
d urin g th e te st me a su re me n t.

• Grima ce . Th e te s t su b je ct sh a ll grima ce b y smilin g o r fro wn in g fo r

1 5 se co n d s.

• Be n d in g Ove r. Th e te s t su b je ct sh a ll b en d a t th e wa ist a s if h e o r
sh e we re to to u ch h is o r he r to e s fo r 1 min u te . Jo g gin g in p la ce
sh a ll b e su b stitu te d fo r this e xe rcise in th o se te st e n viro n me n ts
su ch a s sh ro u d -typ e Q NFT u n its th a t p ro h ibit b e n d in g a t th e wa ist.
Afte r th e b e n d in g o ve r e xe rcise , th e su b je ct sh a ll h o ld his o r h er
h e a d stra igh t a h e a d a n d h old h is o r h er b re a th fo r 1 0 se co n d s
d urin g th e te st me a su re me n t.

• No rma l Bre a th in g. Th e te st su b je ct sh a ll re mo ve a n d re -d o n th e
re spira tor with in a o n e-min u te p erio d . Th e n , in a no rma l sta n d in g
p o sitio n , with o u t ta lkin g, th e su b je ct sh a ll b rea th e n o rma lly fo r 1
min u te . Afte r th e n o rma l b rea th in g e xe rcise , th e su b je ct sh a ll h o ld
his o r h e r h ea d stra igh t a h e a d a n d h old h is o r he r b rea th fo r 1 0
se co n d s d u rin g th e te s t me a su re me n t. Afte r th e te st e xe rcise s, th e
te st su b je ct sh a ll b e qu e stio n e d b y th e te st co n d u cto r re ga rd in g
th e co mfo rt o f th e re sp ira to r u po n co mp le tio n o f th e pro to co l. If it
h a s b e co me u n a cce p ta b le , a n o the r mo d e l o f a re spira tor sh a ll be
trie d .

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 o (c) CN P Te st In stru me n t.

• Th e te st in stru me n t mu st h a ve a n e ffe c tive a u dio -wa rnin g e vice , o r

a visu al-wa rnin g d e vice in th e fo rm o f a scr e e n tra cin g, th a t
in d ica te s wh e n th e te st su b je ct fa ils to h o ld h is or h e r bre a th
d urin g th e te st. Th e te st mu st b e te rmin a te d a n d re sta rte d fro m th e
b e gin nin g wh e n th e te st su b je ct fa ils to h o ld his o r h e r bre a th
d urin g th e te st. Th e te st su b je ct th e n ma y b e re fitte d a n d re te ste d .

• A re co rd o f th e te st sh a ll b e ke p t o n file , a ssu min g th e fit te st wa s

su cce ssfu l. Th e re co rd mu st co n ta in th e te st su b je ct's n a me ;
o ve rall fit fa cto r; ma ke , mo d e l, style a n d size o f re sp ira to r u se d ;
a n d da te te ste d .

6. CONTROLLED NEGATIVE PRESSURE ( CNP) REDON QUANTITATIVE FIT TESTING

PROTOCOL.

o W h e n a d min iste rin g th is p ro to co l to te st su bje cts, e mp lo ye rs mu st co mp ly with

th e re qu ire me n ts sp e cifie d in “Co n tro lle d n e ga tive p re ssu re (CN P) qu a n tita tive
fit te stin g p ro to co l,” a s we ll a s u se th e te st e xe rcise s d e scrib e d b e lo w in ste a d
o f th e te st e xe rcise s sp e cifie d in o th e r te sts.

o E mp lo ye rs mu st e n su re th a t e a ch te st su b j e ct b e in g fit te ste d u sin g th is

p ro to co l fo llo ws th e e xe rcise a n d me a su re me n t p ro ce d ure s, in clu din g th e o rd e r
o f a d ministra tio n de scrib e d in Ta b le A-3 o f th is d o cu me n t.

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Table A-3 - CNP REDON Quantitative Fit Testing Protocol

Measurement
Exercises 1 Exercise procedure procedure

Fa cin g Fo rwa rd Sta n d a n d b re a th e no rma lly, Fa ce fo rwa rd , wh ile

with o u t talkin g, fo r 3 0 se co n d s h old in g b re a th for 1 0
se co n d s.

Be n d in g Ove r Be n d a t th e wa ist, a s if go in g Fa ce p a rallel to th e flo or,

to to u ch h is or h e r to e s, fo r 3 0 wh ile h o ldin g b re a th fo r
se co n d s 1 0 se co n d s

He a d Sh a kin g Fo r a b ou t th re e se co n d s, Fa ce fo rwa rd , wh ile

sh a ke h e a d b a ck a n d fo rth h old in g b re a th for 1 0
vigo ro u sly se ve ra l time s wh ile se co n d s
sh o u tin g

RE D O N 1 Re mo ve th e re sp ira tor ma sk , Fa ce fo rwa rd , wh ile

lo o se n a ll fa ce p ie ce stra p s, h old in g b re a th for 1 0
a n d th en re d o n th e re sp ira to r se co n d s.
ma sk

RE D O N 2 Re mo ve th e re sp ira tor ma sk , Fa ce fo rwa rd , wh ile

lo o se n a ll fa ce p ie ce stra p s, h old in g b re a th for 1 0
a n d th en re d o n th e re sp ira to r se co n d s.
ma sk a ga in

1
E xe rcise s a re liste d in th e ord e r in wh ich th e y a re to be a d min iste red .

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 o Afte r co mp le tin g th e te s t e xe rcise s, th e te s t a d ministra to r mu st qu e stio n e a ch
te st su b je ct re ga rd in g th e co mfo rt o f th e re sp ira to r. W h e n a te st su b je ct sta te s
th a t th e re sp ira tor is u n a cce p ta b le , th e e m plo ye r mu st e n su re th a t th e te st
a d ministra to r re p e a ts th e p ro to col u sin g a n o th er re sp ira to r mo d e l.

o E mp lo ye rs mu st d e te rmin e th e o ve rall fit fa cto r fo r ea ch te st su b je ct b y

ca lcula tin g th e h a rmo n ic me a n o f th e fit te s tin g e xe rcise s a s fo llo ws:

W h e re :

N = Th e n u mb e r o f e xe rcise s;

FF 1 = Th e fit fa cto r fo r th e first e xe rcise ;

FF 2 = Th e fit fa cto r fo r th e se co n d e xe rcise ; a n d

FF N = Th e fit fa cto r fo r th e n th e xe rcise .

Part II. New Fit Test Protocols

o An y p e rso n ma y su b mit to O SH A a n a p p lica tio n fo r a p pro va l o f a n e w fit te st

p ro to co l. If th e a p p lica tio n me e ts th e fo llo w in g criteria , O S HA will in itia te a
rule ma kin g p ro ce e d in g u n d e r se ctio n 6(b )(7 ) o f th e O SH Act to d e te rmin e
wh e th e r to list th e n e w p ro to co l a s a n a p pro ve d p ro to co l in this a p p e n dix A.

o Th e a p plica tion mu st in clu de a d e ta ile d d e scrip tio n o f th e p ro p o se d n e w fit te st

p ro to co l. Th is a p p lica tio n mu st b e su p p o rte d b y e ithe r:

• A te st re p o rt p re p are d b y a n in de p e n d e n t g o ve rn me n t re se arch
la b o ra tory (e .g., L a wre n ce L ivermo re Na tio n al L a b o ra to ry, L o s Ala mo s
Na tio n al L a b ora to ry, th e Na tio n al In stitu te f o r Sta n d a rd s a n d
Te ch n o lo gy) sta tin g th a t th e la b o ra tory h a s te ste d th e p ro to col a n d h a d
fo u n d it to b e a ccu ra te a n d re lia b le ; or

• An a rticle th a t h a s b e e n p u b lish e d in a p ee r-re vie we d in d u stria l h ygie n e

jo u rn al d e scribin g th e p ro to co l a n d e xpla inin g h o w te s t d a ta su p p o rt th e
p ro to co l's a ccu ra cy a n d re lia b ility.

o If O S H A d e te rmin e s th a t a d d itio n al in fo rma tion is re qu ire d be fo re th e A ge n cy

co mme n ce s a ru le ma kin g p ro ce e d in g u n d e r this se ctio n , O SH A will so n o tify th e
a p plica n t a n d a fford th e a p plica n t th e o p po rtun ity to su b mit th e su p p le me n ta l
in fo rma tio n . In itia tion o f a ru le ma kin g p ro ce e din g will b e d e ferre d u n til O SH A h a s
re ceive d a n d e va lua te d th e su p p le me n tal in forma tio n .

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Program Contacts
. Fo r qu e stio n s o r fu rth er in forma tio n re ga rd in g th e Re sp ira to r Fit Te stin g Pro gra m,
p articip an ts sh o u ld co n ta ct th e p ro gra m co o rd in a tor a t
mb o n n e tt@rmi glo b also lu tion s.co m.

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