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CLSI Documents Referenced toThe Joint Commission Laboratory Accreditation Standards Chapters
Updated May 2015
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 1
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Automation and Informatics
AUTO01-A
AUTO02-A2
AUTO03-A2
AUTO04-A
AUTO05-A
AUTO07-A
AUTO08-A
AUTO09-A
AUTO10-A
AUTO11-A2
AUTO12-A
AUTO13-A2
LIS01-A2
LIS02-A2
LIS03-A
LIS04-A
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 2
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Automation and Informatics (Continued)
LIS05-A
LIS06-A
LIS07-A
LIS08-A
LIS09-A
Clinical Chemistry and Toxicology
C24-A3
C29-A2
C31-A2
C34-A3
C37-A
C38-A
C39-A
C40-A2
C42-A
C43-A2
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 3
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Clinical Chemistry and Toxicology (Continued)
C45-A
C46-A2
C48-A
C49-A
C50-A
C52-A2
C56-A
C58-A
C61-A
C62-A
General Laboratory
GP05-A3
GP15-A3
GP16-A3
GP17-A3
GP20-A2
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 4
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
General Laboratory (Continued)
GP23-A2
GP27-A2
GP28-A
GP29-A2
GP31-A
GP33-A
GP34-A
GP36-A
GP39-A6
GP40-A4-AMD
GP41-A6
GP42-A6
GP43-A4
GP44-A4
GP45-A
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 5
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
General Laboratory (Continued)
I08-P
I16-T
Hematology
H02-A5
H07-A3
H15-A3
H20-A2
H21-A5
H26-A2
H30-A2
H42-A2
H43-A2
H47-A2
H48-A
H51-A
H52-A2
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 6
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Hematology (Continued)
H54-A
H56-A
H57-A
H58-A
H59-A
H60-A
Immunology and Ligand Assay
I/LA02-A2
I/LA20-A2
I/LA21-A2
I/LA23-A
I/LA25-A2
I/LA26-A2
I/LA28-A2
I/LA30-A
I/LA33-A
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 7
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Method Evaluation
I/LA34-A
EP05-A3
EP06-A
EP07-A2
EP09-A3
EP10-A3
EP12-A2
EP14-A3
EP15-A3
EP17-A2
EP18-A2
EP19-R
EP21-A
EP23-A™
EP24-A2
EP25-A
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 8
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Method Evaluation (Continued)
EP26-A
EP27-A
EP28-A3c
EP29-A
EP30-A
EP31-A-IR
EP32-R
Microbiology
M02-A12
M06-A2
M07-A10
M11-A8
M15-A
M21-A
M22-A3
M23-A3
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 9
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Microbiology (Continued)
M24-A2
M26-A
M27-A3
M27-S4
M28-A2
M29-A4
M32-P
M33-A
M34-A
M35-A2
M36-A
M38-A2
M39-A4
M40-A2
M41-A
M43-A
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 10
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Microbiology (Continued)
M44-A2
M44-S3
M45-A2
M47-A
M48-A
M50-A
M51-A
M51-S1
M53-A
M54-A
M55-R
M100-S25
Molecular Methods
MM01-A3
MM03-Ed3
MM05-A2
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 11
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Molecular Methods (Continued)
MM06-A2
MM07-A2
MM09-A2
MM10-A
MM11-A
MM12-A
MM13-A
MM14-A2
MM16-A
MM17-A
MM18-A
MM19-A
MM20-A
MM22-A
Newborn Screening
NBS01-A6
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 12
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Newborn Screening (Continued)
NBS02-A2
NBS03-A
NBS04-A
NBS05-A
NBS06-A
Point-of-Care Testing
POCT01-A2
POCT02-A
POCT04-A2
POCT05-A
POCT07-A
POCT08-A
POCT09-A
POCT10-A2
POCT12-A3
POCT13-A2
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
* Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges; sources of error; reagent handling. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ID, identification; LIS, laboratory information system; PT, proficiency testing; QC, quality control. 13
QSA(Quality System Assessment for
Nonwaived Testing) Chapter*
DC
(Doc
umen
t and
Pro
cess
Con
trol
)Te
st O
rder
ing
and
Repo
rtin
g; P
atie
nt
Iden
tifica
tion;
Spe
cim
en C
olle
ctio
n,
Han
dlin
g, a
nd S
tora
ge; D
ocum
ent
Rete
ntio
n an
d W
ritte
n Po
licie
s/
Proc
edur
es
EC (E
nviro
nmen
t of C
are)
Safe
ty; F
acili
ties;
Haz
ardo
us
Mat
eria
ls; L
abor
ator
y Eq
uipm
ent/
Inst
rum
enta
tion
EM (E
mer
genc
y M
anag
emen
t)Em
erge
ncy
Resp
onse
and
Dis
aste
r Pr
epar
edne
ss
HR
(Hum
an R
esou
rces
)Pe
rson
nel Q
ualifi
catio
ns;
Orie
ntat
ion
and
Trai
ning
; Co
mpe
tenc
y
IC (I
nfec
tion
Prev
entio
n an
d Co
ntro
l)Pr
otec
tion,
Pre
vent
ion,
Co
mm
unic
atio
n, a
nd B
ench
Pr
ecau
tions
IM (I
nfor
mat
ion
Man
agem
ent)
LIS
Requ
irem
ents
; Int
erru
ptio
ns a
nd
Back
up P
lan;
Info
rmat
ion
Secu
rity;
D
ata
Stor
age
and
Retr
ieva
l
LD (L
eade
rshi
p)G
over
nanc
e; E
thic
s; Li
cens
ure
and
Accr
edita
tion;
Org
aniz
atio
nal
Stru
ctur
e an
d Se
rvic
es; L
abor
ator
y Pe
rfor
man
ce; D
ata
and
Info
rmat
ion
Revi
ew a
nd R
espo
nsiv
enes
s;
Com
plai
nts,
Reso
lutio
ns, a
nd
Com
mun
icat
ions
NPS
G (N
atio
nal P
atie
nt S
afet
y G
oals
)Pa
tient
ID; C
ritic
al R
esul
ts
Repo
rtin
g; H
and
Hyg
iene
PI (P
erfo
rman
ce Im
prov
emen
t)D
ata
Colle
ctio
n; A
naly
sis;
Pe
rfor
man
ce R
evie
w; C
orre
ctiv
e Ac
tions
WT
(Wai
ved
Test
ing)
CLIA
; Ove
rsig
ht a
nd R
espo
nsib
ility
fo
r Tes
ting;
Test
Per
form
ance
I. Pr
ofici
ency
Test
ing
II. Q
ualit
y Co
ntro
l
III. –
XXI
. Tec
hnic
al
Spec
ialti
es
CLSI Document Referenced
Quality Management Systems
POCT14-A
QMS01-A4
QMS02-A6
QMS03-A3
QMS04-A2
QMS05-A2
QMS06-A3
QMS07-A2
QMS10-A
QMS11-A
QMS12-A
QMS13-A
QMS14-A
QMS14-AES
QMS15-A
QMS20-R
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